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NDC 63645-0179-06 CPH Anti-bacterial Breath Mist 1.11 g/13mL Details

CPH Anti-bacterial Breath Mist 1.11 g/13mL

CPH Anti-bacterial Breath Mist is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by OraLabs. The primary component is CETYLPYRIDINIUM CHLORIDE.

Product Information

NDC	63645-0179
Product ID	63645-179_c421c473-d1b7-4ba5-a562-1c29f64e9b43
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CPH Anti-bacterial Breath Mist
Proprietary Name Suffix	n/a
Non-Proprietary Name	Cetylpyridinium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	1.11
Active Ingredient Units	g/13mL
Substance Name	CETYLPYRIDINIUM CHLORIDE
Labeler Name	OraLabs
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63645-0179-06 (63645017906)

Pricing Information	N/A
NDC Package Code	63645-179-06
Billing NDC	63645017906
Package	13 mL in 1 BOTTLE (63645-179-06)
Marketing Start Date	2022-04-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c421c473-d1b7-4ba5-a562-1c29f64e9b43 Details

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

INGREDIENTS AND APPEARANCE

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)

Revised: 4/2022

Document Id: c421c473-d1b7-4ba5-a562-1c29f64e9b43

Set id: c421c473-d1b7-4ba5-a562-1c29f64e9b43

Version: 1

Effective Time: 20220418