KALAYA BREATH REFRESH- mouthwash liquid 
Avaria Health and Beauty Corp

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.

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Kalaya Breath Refresh Antiseptic Oral Rinse-updated label for NDC

Active Ingredients

Keep out of reach of children

Purpose

Inactive Ingredients

Warnings

Uses

Directions

Kalaya Oral Rinse PDP

KALAYA BREATH REFRESH 
mouthwash liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43493-0005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorPEPPERMINT, SPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43493-0005-1500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/16/2018
Labeler - Avaria Health and Beauty Corp (251366043)

Revised: 12/2022
Document Id: f057426a-d671-6b61-e053-2a95a90a4d13
Set id: 750e99ff-72e4-3c2f-e053-2a91aa0ad5a0
Version: 7
Effective Time: 20221221
 
Avaria Health and Beauty Corp