Label: ORAJEL TOOTHACHE RINSE- benzyl alcohol, zinc chloride liquid
- NDC Code(s): 10237-764-08, 10237-764-16
- Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 27, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
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STOP USE
Stop use and see your physician promptly if• swelling, rash or fever develops • irritation, pain or redness persists or worsens • sore mouth symptoms do not improve in 7 days • allergic reaction occurs • sore thoat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
•remove imprinted safety seal from bottle cap
• to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed.
Adults and children 2 years of age or over:
Swish one-half capful (2 teaspoons = 10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare provider
Children under 12 years of age:
Should be supervised in the use of this product
Children under 2 years of age:
Consult a dentist or healthcare provider
Other Information •cap tightly • keep away from heat or direct sunlight • do not use if safety seal is broken or missing
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ORAJEL TOOTHACHE RINSE
benzyl alcohol, zinc chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-764 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL 2.7 mg in 1 mL ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 1.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength METHYL SALICYLATE (UNII: LAV5U5022Y) POLOXAMER 338 (UNII: F75JV2T505) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CALCIUM DISODIUM PYROPHOSPHATE (UNII: T9L63LWS5A) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-764-16 473.2 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2016 2 NDC:10237-764-08 236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 12/01/2016 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc 253933600 manufacture(10237-764)