Label: FAMILY WELLNESS ORIGINAL AMBER- eucalyptol, menthol, methyl salicylate, thymol mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 55319-232-23, 55319-232-86 - Packager: Family Dollar Services Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated August 23, 2021
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FAMILY WELLNESS ORIGINAL AMBER
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-232 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL 0.092 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.042 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.06 g in 100 mL THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL 0.064 g in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) POLOXAMER 407 (UNII: TUF2IVW3M2) BENZOIC ACID (UNII: 8SKN0B0MIM) CARAMEL (UNII: T9D99G2B1R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-232-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/20/2019 2 NDC:55319-232-23 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/20/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/20/2019 Labeler - Family Dollar Services Inc. (024472631)