CPH ANTI-BACTERIAL BREATH MIST- cetylpyridinium chloride spray
OraLabs

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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Drug Facts

Active ingredient

Cetylpyridinium chloride 0.09%

Purpose

Antibacterial

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Uses

Helps fight odor causing bacteria

Warnings

For external use only:

Do not use this product if gums are irritated or bleeding unless directed to do by a doctor or dentist. If more than twice the recommended amount for tongue spraying is accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not spray into the eyes. Do not spray into the eyes. If spray gets into the eyes, hold eyelids apart and flush the eye continuously with running water for at least 15 minutes.

Directions

Adults and children 12 years of age and older: Spray 3 times in the oral cavity. Children 6-12 years of age: Supervise use. Children under 6 years: Do not use.

Inactive Ingredients

Citric Acid, Flavor, Glycerin, Menthol, PEG-40 Hydrogenated Castor Oil, Potassium Sorbate, Sodium Benzoate, Sucralose, Water.

Package/Label Principal Display Panel

CPH ANTI-BACTERIAL BREATH MIST
cetylpyridinium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63645-179
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	1.11 g in 13.0 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	11.18 mL in 13.0 mL
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)	1.3 mL in 13.0 mL
MENTHOL, (+)- (UNII: C6B1OE8P3W)	.0065 mL in 13.0 mL
SUCRALOSE (UNII: 96K6UQ3ZD4)	.039 mL in 13.0 mL

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63645-179-06	13.0 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	04/15/2022

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Name	Address	ID/FEI	Business Operations
Establishment
OraLabs		801824756	MANUFACTURE(63645-179) , LABEL(63645-179)