Label: ORAJEL GUM PAIN 3X MEDICATED- benzocaine, menthol, zinc chloride gel
- NDC Code(s): 10237-792-12, 10237-792-42
- Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 20, 2023
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Warnings
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
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INGREDIENTS AND APPEARANCE
ORAJEL GUM PAIN 3X MEDICATED
benzocaine, menthol, zinc chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-792 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 ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 1.5 mg in 1 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 2.6 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) METHYL SALICYLATE (UNII: LAV5U5022Y) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBIC ACID (UNII: X045WJ989B) PEG-75 LANOLIN (UNII: 09179OX7TB) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-792-12 1 in 1 PACKAGE 12/17/2019 1 3.5 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10237-792-42 1 in 1 CARTON 12/17/2019 2 11.9 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 DRUG M022 12/17/2019 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 MANUFACTURE(10237-792)