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
- 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 August 7, 2020
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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
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
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ORAJEL MEDICATED FOR TOOTHACHE AND GUM, LIQUID
benzocaine and menthol liquid
Product 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 g in 1 mg MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g in 1 mg 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 mg 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 not final part356 08/07/2020 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Accupac 071609663 manufacture(10237-796)