Label: KALAYA BREATH REFRESH- mouthwash liquid
- NDC Code(s): 43493-0005-1
- Packager: Avaria Health and Beauty Corp
- 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 December 21, 2022
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- INACTIVE INGREDIENT
- WARNINGS
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KALAYA BREATH REFRESH
mouthwash liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43493-0005 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSES (UNII: 3NXW29V3WO) WATER (UNII: 059QF0KO0R) POLOXAMER 407 (UNII: TUF2IVW3M2) PEPPERMINT OIL (UNII: AV092KU4JH) SPEARMINT OIL (UNII: C3M81465G5) Product Characteristics Color Score Shape Size Flavor PEPPERMINT, SPEARMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43493-0005-1 500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 11/16/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 11/16/2018 Labeler - Avaria Health and Beauty Corp (251366043)
