Label: HANDY SOLUTIONS COOL MINT LISTERINE ANTISEPTIC MOUTHWASH- eucalyptol, menthol, methyl salicylate, and thymol mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 67751-103-01 - Packager: Navajo Manufacturing Company 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 November 25, 2019
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- Handy Solutions Cool Mint LISTERINE ANTISEPTIC MOUTHWASH
- ACTIVE INGREDIENT
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- Handy Solutions Cool Mint LISTERINE ANTISEPTIC MOUTHWASH 95ml (67751-103-01)
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INGREDIENTS AND APPEARANCE
HANDY SOLUTIONS COOL MINT LISTERINE ANTISEPTIC MOUTHWASH
eucalyptol, menthol, methyl salicylate, and thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-103 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL 0.92 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.42 mg in 1 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.6 mg in 1 mL THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL 0.64 mg in 1 mL Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) SORBITOL (UNII: 506T60A25R) POLOXAMER 407 (UNII: TUF2IVW3M2) BENZOIC ACID (UNII: 8SKN0B0MIM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67751-103-01 95 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/21/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 08/21/2013 Labeler - Navajo Manufacturing Company Inc. (091917799) Establishment Name Address ID/FEI Business Operations Navajo Manufacturing Company Inc 136941411 repack(67751-103) , relabel(67751-103) Establishment Name Address ID/FEI Business Operations Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. 801375143 manufacture(67751-103)