Label: ORAJEL 3X MEDICATED FOR ALL MOUTH SORES- benzocaine, menthol, zinc chloride gel
- NDC Code(s): 10237-783-12, 10237-783-18, 10237-783-42
- 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.
Updated January 13, 2022
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
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
- Other information
- INACTIVE INGREDIENT
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ORAJEL 3X MEDICATED FOR ALL MOUTH SORES
benzocaine, menthol, zinc chloride gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-783 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 MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 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 CARBOMER 934 (UNII: Z135WT9208) POVIDONE (UNII: FZ989GH94E) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYL SALICYLATE (UNII: LAV5U5022Y) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 60 (UNII: CAL22UVI4M) SORBIC ACID (UNII: X045WJ989B) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) ALLANTOIN (UNII: 344S277G0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-783-18 1 in 1 PACKAGE 11/01/2019 1 1.8 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10237-783-42 1 in 1 PACKAGE 11/01/2019 2 4.2 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:10237-783-12 1 in 1 PACKAGE 11/01/2019 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(10237-783)