Label: ORAJEL FOR COLD SORES DOUBLE MEDICATED, CREAM- benzocaine and white petrolatum cream
- NDC Code(s): 10237-797-12
- Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 10, 2023
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- ACTIVE INGREDIENT
- QUESTIONS
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: • pale, gray, or blue colored skin (cyanosis) • headache • rapid heart rate • shortness of breath • dizziness or lightheadedness • fatigue or lack of energy
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- cut open tube of tip on score mark
- Do not use if tip is cut prior to opening
Adults and Children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
Children betweem 2 and 12 years of age: Ask a doctor before use. Should be supervised in the use of this product
Children under 2 years of age: Do not use
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ORAJEL FOR COLD SORES DOUBLE MEDICATED, CREAM
benzocaine and white petrolatum creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-797 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 736.4 mg in 1 g Inactive Ingredients Ingredient Name Strength CHOLECALCIFEROL (UNII: 1C6V77QF41) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PRUNELLA VULGARIS FLOWERING TOP (UNII: ID3IB81B1C) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) WATER (UNII: 059QF0KO0R) CORN OIL (UNII: 8470G57WFM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-797-12 1 in 1 CARTON 01/18/2021 1 3.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 01/18/2021 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 MANUFACTURE(10237-797)
