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Orajel PM 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 PM 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 plus chamomile for fast topical pain relief, so you can get a good night’s sleep.
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: April 26, 2025500 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.
Advanced
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.Percent of chemical in preparation.
% Conc.Purpose served by this chemical
FunctionChemical of Concern (CoC)
Chemical of Concern(CoC)Ammonium glycyrrhizate 053956-04-0 -- Flavor No Chamomilla Recutita (Matricaria) Flower Extract 084082-60-0 0.1-1.0 Botanical No Flavor(s) 999999-56-2 -- Withheld as CBI No PEG-8 005117-19-1 -- Delivery vehicle No PEG-75 999999-88-4 -- Delivery vehicle No PEG/PPG 116/66 Copolymer 888888-04-5 -- Viscosity Adjuster No Poloxamer-407 977057-91-2 -- Texturizer No Sodium saccharin 000128-44-9 -- Sweetener No Sorbic acid 000110-44-1 -- Preservative No Titanium dioxide 013463-67-7 0.1-1.0 Whitening agent Yes CoC List
Water 007732-18-5 -- Solvent No Benzalkonium chloride 008001-54-5 -- Active Ingredient Yes CoC List
Benzocaine 000094-09-7 10.0-30.0 Active Ingredient No Menthol 001490-04-6 -- Active Ingredient No Zinc chloride 007646-85-7 0.145-0.155 Active Ingredient No Glycerin 000056-81-5 <1 -- No Glycols, polyethylene 025322-68-3 60.0-80.0 -- No Click on each chemical for information on chemical structure, properties and health effects.
Click on Chemical, CAS No./ID headings to sort values.
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.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.
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.UN Global Harmonization Classification
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).Ammonium glycyrrhizate 053956-04-0 258-887-7 -- H319 ------- No Chamomilla Recutita (Matricaria) Flower Extract 084082-60-0 282-006-5 0.1-1.0 H304, H315, H317, H319, H411 P264, P280, P301+P310, P305+P351+P338, P362+P364, P501, P391 No Flavor(s) 999999-56-2 -- -- -------- ------- ---- No PEG-8 005117-19-1 225-856-4 -- -------- ------- ---- No PEG-75 999999-88-4 -- -- -------- ------- ---- No PEG/PPG 116/66 Copolymer 888888-04-5 -- -- -------- ------- ---- No Poloxamer-407 977057-91-2 -- -- -------- ------- ---- No Sodium saccharin 000128-44-9 204-886-1 -- -------- ------- ---- No Sorbic acid 000110-44-1 203-768-7 -- H315, H319, H335 P260, P262, P305+P351+P338, P337+P313 No Titanium dioxide 013463-67-7 236-675-5 0.1-1.0 -------- ------- ---- No Water 007732-18-5 231-791-2 -- -------- ------- ---- No Benzalkonium chloride 008001-54-5 -- -- -------- ------- ---- No Benzocaine 000094-09-7 202-303-5 10.0-30.0 H317, H370 ------- No Menthol 001490-04-6 216-074-4 -- H315, H315, H319 ------- No Zinc chloride 007646-85-7 231-592-0 0.145-0.155 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 Glycerin 000056-81-5 200-289-5 <1 -------- ------- ---- No Glycols, polyethylene 025322-68-3 500-038-2 60.0-80.0 -------- ------- ---- 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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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 -
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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