Label: ORAJEL MEDICATED FOR TOOTHACHE AND GUM, LIQUID- benzocaine and menthol liquid
- NDC Code(s): 10237-796-45
- Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 2, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Methemoglobinemia warning: Use of this product may cuse methemoglobinemia, a serious condition that must be treated promptly becasue it reduces the amount of oxygen carried in the 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 or 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
Flammable: keep away from fire or flame. Avoid smoking during application.
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions • remove imprinted safety seal from bottle cap
Adults and children 2 years of age and over
- Apply product with cotton swab or finger to the affected area. Use up to 4 times daily or as directed by a dentist or doctor
Children under 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
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ORAJEL MEDICATED FOR TOOTHACHE AND GUM, LIQUID
benzocaine and menthol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-796 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 mL MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength METHYL SALICYLATE (UNII: LAV5U5022Y) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ALCOHOL (UNII: 3K9958V90M) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) Product Characteristics Color ORANGE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-796-45 1 in 1 CARTON 08/07/2020 1 13.3 mL in 1 BOTTLE, GLASS; 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 08/07/2020 Labeler - Church & Dwight Co., Inc. (001211952)