KALAYA BREATH REFRESH- mouthwash liquid

Kalaya Breath Refresh by

Drug Labeling and Warnings

Kalaya Breath Refresh by is a Otc medication manufactured, distributed, or labeled by Avaria Health and Beauty Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

KEEP OUT OF REACH OF CHILDREN

PURPOSE

INACTIVE INGREDIENT

WARNINGS

INDICATIONS & USAGE

DOSAGE & ADMINISTRATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KALAYA BREATH REFRESH 
mouthwash liquid

Product 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 (248926979)