MOUTH FRESH - cetylpyridinium chloride spray 
Yuyao Jessie Commodity Co.,Ltd.

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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Antibacterial Wet Wipes

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

label

MOUTH FRESH 
cetylpyridinium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51414-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.05 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51414-500-012 mL in 1 PACKAGE
2NDC:51414-500-023 mL in 1 PACKAGE
3NDC:51414-500-034 mL in 1 PACKAGE
4NDC:51414-500-045 mL in 1 PACKAGE
5NDC:51414-500-056 mL in 1 PACKAGE
6NDC:51414-500-067 mL in 1 PACKAGE
7NDC:51414-500-078 mL in 1 PACKAGE
8NDC:51414-500-089 mL in 1 PACKAGE
9NDC:51414-500-0910 mL in 1 PACKAGE
10NDC:51414-500-1015 mL in 1 PACKAGE
11NDC:51414-500-1120 mL in 1 PACKAGE
12NDC:51414-500-1225 mL in 1 PACKAGE
13NDC:51414-500-1330 mL in 1 PACKAGE
14NDC:51414-500-1435 mL in 1 PACKAGE
15NDC:51414-500-1540 mL in 1 PACKAGE
16NDC:51414-500-1645 mL in 1 PACKAGE
17NDC:51414-500-1750 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/12/2012
Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)
Establishment
NameAddressID/FEIBusiness Operations
Yuyao Jessie Commodity Co.,Ltd.529892305manufacture(51414-500)

Revised: 9/2012
Document Id: b4b2224e-107c-4ede-9f59-944acd52e97f
Set id: a8892189-9f79-4831-b157-5e99544ab8a9
Version: 1
Effective Time: 20120912
 
Yuyao Jessie Commodity Co.,Ltd.