MOUTH FRESH- cetylpyridinium chloride spray

mouth fresh by

Drug Labeling and Warnings

mouth fresh by is a Otc medication manufactured, distributed, or labeled by Yuyao Jessie Commodity Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Cetylpyridinium Chloride 0.05%

Purpose

Sterilization

Use

sterilization

WARNINGS

For External use only.
Do not use  if you are allergic to any of the ingredients.
When using this product Do not get into eyes,if contact occurs ,rinse throughly with water.
Discontinue use if irritation or redness develops if condition persists for more than 72 hours consults a physician.

keep out of reach of children

 keep out of reach of children unless under adult supervision .if seallowed ,get medical help or contact a Poison Control Center immediately.

Directions

Open Cap to on position exposing nozzle Pump 1-2 sprays directly into mouth.

Children under 6 months of age:ask a doctor

Inactive ingredients

WATER (Aqua ),Alcohol,Glycerin,Sorbitol,Aroma,PEG-40 hydrogenated Castor Oil,Sodium Benzoate,Citric Acid ,Limonene

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MOUTH FRESH 
cetylpyridinium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51414-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.05 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
CHLOROMETHYL METHYL ETHER (UNII: 334G5B96VG)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
QUATERNIUM-15 (UNII: E40U03LEM0)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51414-500-01	2 mL in 1 PACKAGE
2	NDC: 51414-500-02	3 mL in 1 PACKAGE
3	NDC: 51414-500-03	4 mL in 1 PACKAGE
4	NDC: 51414-500-04	5 mL in 1 PACKAGE
5	NDC: 51414-500-05	6 mL in 1 PACKAGE
6	NDC: 51414-500-06	7 mL in 1 PACKAGE
7	NDC: 51414-500-07	8 mL in 1 PACKAGE
8	NDC: 51414-500-08	9 mL in 1 PACKAGE
9	NDC: 51414-500-09	10 mL in 1 PACKAGE
10	NDC: 51414-500-10	15 mL in 1 PACKAGE
11	NDC: 51414-500-11	20 mL in 1 PACKAGE
12	NDC: 51414-500-12	25 mL in 1 PACKAGE
13	NDC: 51414-500-13	30 mL in 1 PACKAGE
14	NDC: 51414-500-14	35 mL in 1 PACKAGE
15	NDC: 51414-500-15	40 mL in 1 PACKAGE
16	NDC: 51414-500-16	45 mL in 1 PACKAGE
17	NDC: 51414-500-17	50 mL in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	09/12/2012

Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)

Establishment
Name	Address	ID/FEI	Business Operations
Yuyao Jessie Commodity Co.,Ltd.		529892305	manufacture(51414-500)