Label: ORAJEL 3X MEDICATED FOR TOOTHACHE AND GUM- benzocaine, menthol, zinc chloride gel
- NDC Code(s): 10237-790-12, 10237-790-25, 10237-790-42
- 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 13, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- Use
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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
- DO NOT USE
- Stop use and ask a doctor if
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- INACTIVE INGREDIENT
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ORAJEL 3X MEDICATED FOR TOOTHACHE AND GUM
benzocaine, menthol, zinc chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-790 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.6 mg in 1 g 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) METHYL SALICYLATE (UNII: LAV5U5022Y) SACCHARIN SODIUM (UNII: SB8ZUX40TY) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) PEG-75 LANOLIN (UNII: 09179OX7TB) SORBIC ACID (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-790-25 1 in 1 PACKAGE 11/01/2019 1 2.5 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10237-790-42 1 in 1 PACKAGE 11/01/2019 2 4.2 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:10237-790-12 1 in 1 PACKAGE 11/01/2019 06/10/2023 3 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 part348 11/01/2019 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 manufacture(10237-790)