KALAYA BREATH REFRESH- mouthwash liquid
Avaria Health and Beauty Corp
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Kalaya Breath Refresh Antiseptic Oral Rinse-updated label for NDC
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 Drug
M022
11/16/2018
Labeler -
Avaria Health and Beauty Corp (251366043)
Revised: 10/2024
Document Id:
24aec735-efd2-adc8-e063-6394a90a1a67
34390-5
Set id: 750e99ff-72e4-3c2f-e053-2a91aa0ad5a0
Version: 8
Effective Time: 20241017
Avaria Health and Beauty Corp