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Orajel 4X Medicated For Toothache & Gum Cream-06/28/2021
Products in this Consumer Product Information Database (CPID) are classified based on their composition:
Substances: single chemicals
Preparations: products which contain chemicals that can be easily separated during normal use
Articles: products or product assemblies that do not contain chemicals that can be separated out from the product or assembly under normal or advertised use.
Classification: Preparation
Indicates country where product is sold.
Market: US/CanadaOrajel 4X Medicated For Toothache & Gum Cream provides instant pain relief for severe toothaches and painful gums. The formula combines the power of four active ingredients for fast topical pain relief.
Purpose of product.
Usage: Toothache treatmentStructure such as solid, liquid, aerosol etc.
Form: creamDate when validity of Material Safety Data Sheet (MSDS) or Safety Data Sheet (SDS) was last verified.
Date verified: February 15, 2024500 Charles Ewing Boulevard
Ewing NJ 08628
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Chemical Composition/Ingredients
The GHS is an acronym for The Globally Harmonized System of Classification and Labelling of Chemicals. The GHS is a system for standardizing and harmonizing the classification and labelling of chemicals. Chemicals are associated with codes that define their health, physical and environmental hazards.This universal hazard communication system was developed to ensure that employers, employees and consumers are provided with adequate, practical, reliable and comprehensible information on the hazards of chemicals, so that they can take effective preventive and protective measure for their own health and safety.
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The GHS classifications for chemicals associated with products in this database may be viewed by selecting the "Advanced" button on the Chemical Ingredients tables. Since this is a work in progress, GHS classifications may not be shown for all chemical ingredients.-
Primary Chemical Name is the standard name assigned to a chemical substance.
ChemicalChemical Abstracts Service Registry Number is a unique identifier for a chemical and its synonyms. CAS numbers identify the chemical, but not its concentration or specific mixture. CAS Registry Numbers are assigned by the Chemical Abstracts Service, a division of the American Chemical Society. For more information: www.cas.org
CAS No./ID
We have assigned "ID numbers" (with 6 leading zeros or nines, e.g., 000000-xx-x , 888888-xx-x) or 999999-xx-x) for blends and chemicals that do not have CAS numbers.Is a seven-digit number (xxx-xxx-x) assigned by the European Commission to chemicals contained in three inventories:
EC No.
EINECS is the European Inventory of Existing Commercial Substances and its EINECS numbers are displayed as 2xx-xxx-x.
ELINCS is the European List of Notified Chemical Substances that was available after September 18, 1981 and its ELINCS numbers are displayed as 4xx-xxx-x.
NLP is the No-Longer Polymers category and its NLP numbers are displayed as 5xx-xxx-xPercent of chemical in preparation.
% Conc.REACH COMPLIANCE
EU Hazard Classification Directive 67/548/EECHazard Symbols are used to classify dangerous substances.
Hazard SymbolsRisk Phrases, denoted as a series of numbers preceded by the letter "R" indicate the nature of the special risks, in accordance with Annex III to Directive 67/548/EEC (see Article 23(2)(d) Directive 67/548/EEC). The numbers are separated by either a comma to denote separate statements concerning special risks, or an oblique stroke (/) to denote a combined statement, in a single sentence, of the special risks.
Risk PhrasesSafety Phrases, denoted as a series of numbers preceded by the letter "S" indicating the recommended safety precautions, in accordance with Annex IV to Directive 67/548/EEC. The numbers are separated by either a comma to denote separate statements concerning safety precautions, or an oblique stroke (/) to denote a combined statement, in a single sentence, of the safety precautions.
Safety PhrasesSVHC is a substance (identified by the European Chemicals Agency) that may have serious and often irreversible effects on human health and the environment. SVHC are defined in Article 57 of Regulation (EC) No 1907/2006 (“the REACH Regulation”) and include substances which are:
SVHC?
1. Carcinogenic, Mutagenic or toxic to Reproduction (CMR), meeting the criteria for classification in category 1 or 2 in accordance with Directive 67/548/EEC or in category 1a or 1b in accordance with EC No 1272/2008This directive was recently replaced by the new EU regulation (EC) No 1272/2008.
2. Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation, or
3. Identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to human health or the environment of an equivalent level of concern as those above (e.g. endocrine disrupters).-- 053956-04-0 -- -- -- -- -- 999999-56-2 -- -- -- -- -- 005117-19-1 -- -- -- -- -- 025322-68-3 -- 60.0-80.0 -- -- -- -- 888888-04-5 -- -- -- -- -- 977057-91-2 -- -- -- -- -- 000128-44-9 -- -- -- -- -- 000110-44-1 -- -- -- -- -- 013463-67-7 -- 0.1-1.0 -- -- -- -- 007732-18-5 -- -- -- -- -- 008001-54-5 -- -- -- -- -- 000094-09-7 -- 10.0-30.0 -- -- -- -- 001490-04-6 -- -- -- -- -- 007646-85-7 -- 0.145-0.155 Xn, C, N -- -- -- -- 000056-81-5 -- <1 -- -- -- Click on each chemical for information on chemical structure, properties and health effects.
Click on Chemical, CAS No./ID or EC No. headings to sort values.Sources for Chemical Classifications- European Commission>JRC>IHCP>European chemical Substances Information System (ESIS) Table 3.2
- European Chemicals Agency, http://echa.europa.eu/
ECHA Disclaimer: http://echa.europa.eu/web/guest/legal-notice
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Primary Chemical Name is the standard name assigned to a chemical substance.
Chemical Function Purpose served by this chemical.Chemical Abstracts Service Registry Number is a unique identifier for a chemical and its synonyms. CAS numbers identify the chemical, but not its concentration or specific mixture. CAS Registry Numbers are assigned by the Chemical Abstracts Service, a division of the American Chemical Society. For more information: www.cas.org
CAS No./ID
We have assigned "ID numbers" (with 6 leading zeros or nines, e.g., 000000-xx-x , 888888-xx-x) or 999999-xx-x) for blends and chemicals that do not have CAS numbers.Is a seven-digit number (xxx-xxx-x) assigned by the European Commission to chemicals contained in three inventories:
EC No.
EINECS is the European Inventory of Existing Commercial Substances and its EINECS numbers are displayed as 2xx-xxx-x.
ELINCS is the European List of Notified Chemical Substances that was available after September 18, 1981 and its ELINCS numbers are displayed as 4xx-xxx-x.
NLP is the No-Longer Polymers category and its NLP numbers are displayed as 5xx-xxx-xPercent of chemical in preparation.
% Conc.California Prop.65 Chemical?The GHS is an acronym for The Globally Harmonized System of Classification and Labelling of Chemicals. The GHS is a system for standardizing and harmonizing the classification and labelling of chemicals. Chemicals are associated with codes that define their health, physical and environmental hazards.This universal hazard communication system was developed to ensure that employers, employees and consumers are provided with adequate, practical, reliable and comprehensible information on the hazards of chemicals, so that they can take effective preventive and protective measure for their own health and safety.
UN Global Harmonization Classification
The GHS classifications for chemicals associated with products in this database may be viewed by selecting the "Advanced" button on the Chemical Ingredients tables. Since this is a work in progress, GHS classifications may not be shown for all chemical ingredients.Hazard Codes and their associated descriptions are an essential part of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). There are 4 categories of Hazard Codes:
- Physical Hazard Codes (H200 series)
- Health Hazard Codes (H300 series)
- Environmental Hazard Codes (H400 series)
- Supplementary Hazard Codes (EUH series)
Hazard Codes may be found in the "Advanced" version of Chemical Composition / Ingredients tables.
Hazard Statement CodePrecautionary Codes and their associated descriptions are an essential part of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Precautionary Code
Precautionary Codes may be found in the "Advanced" version of Chemical Composition / Ingredients tables.PictogramSVHC is a substance (identified by the European Chemicals Agency) that may have serious and often irreversible effects on human health and the environment. SVHC are defined in Article 57 of Regulation (EC) No 1907/2006 (“the REACH Regulation”) and include substances which are:
SVHC?
1. Carcinogenic, Mutagenic or toxic to Reproduction (CMR), meeting the criteria for classification in category 1 or 2 in accordance with Directive 67/548/EEC or in category 1a or 1b in accordance with EC No 1272/2008This directive was recently replaced by the new EU regulation (EC) No 1272/2008.
2. Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation, or
3. Identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to human health or the environment of an equivalent level of concern as those above (e.g. endocrine disrupters).Endocrine Disruptor (ED)Ammonium glycyrrhizate
Flavor
053956-04-0
258-887-7-- No H319 -- No No Flavor(s)
Withheld as CBI
999999-56-2
---- No -- -- -- No No PEG-8
Delivery vehicle
005117-19-1
225-856-4-- No -- -- -- No No Glycols, polyethylene
Delivery vehicle
025322-68-3
500-038-260.0-80.0 No -- -- -- No No PEG/PPG 116/66 Copolymer
Viscosity Adjuster
888888-04-5
---- No -- -- -- No No Poloxamer-407
Texturizer
977057-91-2
---- No -- -- -- No No Sodium saccharin
Sweetener
000128-44-9
204-886-1-- No -- -- -- No No Sorbic acid
Preservative
000110-44-1
203-768-7-- No H315, H319, H335 P260, P262, P305+P351+P338, P337+P313 No No Titanium dioxide
Whitening agent
013463-67-7
236-675-50.1-1.0 No -- -- -- No No Water
Solvent
007732-18-5
231-791-2-- No -- -- -- No No Benzalkonium chloride
Active Ingredient
008001-54-5
---- No -- -- -- No No Benzocaine
Active Ingredient
000094-09-7
202-303-510.0-30.0 No H317, H370 -- No No Menthol
Active Ingredient
001490-04-6
216-074-4-- No H315, H315, H319 -- No No Zinc chloride
Active Ingredient
007646-85-7
231-592-00.145-0.155 No H302, H314, H400, H410 P260, P264, P270, P273, P280, P301+P312, P301+P330+P331, P303+P361+P353, P304+P340, P305+P351+P338, P321, P363, P391, P405, P501 No No Glycerin
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000056-81-5
200-289-5<1 No -- -- -- No No Click on each chemical for information on chemical structure, properties and health effects.
Click on Chemical, CAS No./ID or EC No. headings to sort values.
Sources for Chemical Classifications- European Commission>JRC>IHCP>European chemical Substances Information System (ESIS) Table 3.1
- European Chemicals Agency, http://echa.europa.eu/
ECHA Disclaimer: http://echa.europa.eu/web/guest/legal-notice
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Hazard Statements
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- Code
- Statement
- H302 : Harmful if swallowedH314 : Causes severe skin burns and eye damageH315 : Causes skin irritationH317 : May cause an allergic skin reactionH319 : Causes serious eye irritationH335 : May cause respiratory irritationH370 : Causes damage to organsH400 : Very toxic to aquatic lifeH410 : Very toxic to aquatic life with long lasting effects
- P260 : Do not breathe dust/fume/gas/mist/vapours/sprayP262 : Do not get in eyes, on skin, or on clothingP264 : Wash … thoroughly after handlingP270 : Do not eat, drink or smoke when using this productP273 : Avoid release to the environmentP280 : Wear protective gloves/protective clothing/eye protection/face protectionP321 : Specific treatment (see … on this label)P363 : Wash contaminated clothing before reuseP391 : Collect spillageP301+P312 : IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwellP301+P330+P331 : IF SWALLOWED: Rinse mouth. Do NOT induce vomitingP303+P361+P353 : IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/showerP304+P340 : IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathingP305+P351+P338 : IF IN EYES: Rinse continuously with water for several minutes. Remove contact lenses if present and easy to doP337+P313 : Get medical advice/attentionP405 : Store locked upP501 : Dispose of contents/container to
- GHS05 : CorrosiveGHS07 : IrritantGHS08 : Health HazardGHS09 : Environmentally Hazardous
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Health Effects Information
Ingredients and Health Effects Information are taken from the manufacturer's product label and/or the Safety Data Sheet (SDS). Products are not tested and manufacturer's information presented here is not evaluated by DeLima Associates.
View Safety Data Sheet(SDS) Date that the Safety Data Sheet (SDS) was issued by manufacturer of a specific product.
SDS DATE :June 28, 2021 Measure of Alkalinity/Acidity of substance or preparation where a level of 7 is considered as neutral.
pH Levels4.0-5.0 -
SVHC declaration
This product does not contain any Substances of Very High Concern (SVHC).
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Warnings
Hazard statements
Warning. May cause an allergic skin reaction. May cause respiratory irritation. Harmful to aquatic life.
Precautionary Statements
General
None.
Prevention
Avoid breathing vapors, mist, or spray. Use only outdoors or in a well-ventilated area. Contaminated work clothing should not be allowed out of the workplace. Avoid release to the environment. Wear protective gloves, protective clothing, and eye protection.
Response
IF ON SKIN: Wash with plenty of water. If skin irritation or rash occurs: Get medical advice/attention. Take off contaminated clothing and wash it before reuse.
IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER or doctor if you feel unwell.
Storage
Store in a well-ventilated place. Keep container tightly closed. Store locked up.
Disposal
Dispose of contents/container in accordance with local, regional, national, and international regulations. -
Acute health effects
From SDS:
Hazards Identification
Emergency Overview
Warning. May cause an allergic skin reaction. May cause respiratory irritation. Harmful to aquatic life.
Potential Health Effects
Eye Contact: May cause slight irritation to eyes.
Skin Contact: May cause an allergic skin reaction.
Inhalation: Irritation of the respiratory tract and the other mucous membranes.
Ingestion: Ingestion may cause adverse effects. -
Chronic health effects
From SDS:
None known. -
Carcinogenicity
Not classified. (There have been studies performed in animals that suggest Titanium Dioxide may cause lung cancer through inhalation. However, this hazard is not associated with other routes of exposure. Since this product is in a paste form, the Titanium Dioxide is not able to become airborne and cannot be inhaled. Thus, the hazards usually associated with Titanium Dioxide are not applicable to this product.)
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Handling information
Contains substances that are combustible dusts. If dried and allowed to accumulate, may form combustible dust concentrations in air that could ignite and cause an explosion. Take appropriate precautions. Avoid breathing vapors, mist, spray. Avoid contact with eyes, skin and clothing. Wash hands and other exposed areas with mild soap and water before eating, drinking or smoking and when leaving work. Keep container closed when not in use. Store in a dry, cool place. Keep/Store away from direct sunlight, extremely high or low temperatures and incompatible materials. Store locked up/in a secure area
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Disposal information
Dispose of contents/container in accordance with local, regional, national, and international regulations.
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First Aid
Eye Contact: Remove contact lenses, if present and easy to do. Continue rinsing. Rinse cautiously with water for at least 15 minutes. Obtain medical attention.
Skin Contact: Remove contaminated clothing. Drench affected area with water for at least 15 minutes. Obtain medical attention if irritation/rash develops or persists.
Inhalation: When symptoms occur: go into open air and ventilate suspected area. Obtain medical attention if breathing difficulty persists.
Ingestion: Rinse mouth. Do NOT induce vomiting. Obtain medical attention.
General: Never give anything by mouth to an unconscious person. If you feel unwell, seek medical advice (show the label where possible).
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