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
- 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 10, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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 NOT FINAL part356 12/01/2016 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc 253933600 MANUFACTURE(10237-764)
