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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mouth fresh 500-501

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:51414-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.05 g  in 100 g
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:51414-501-012 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2018
2NDC:51414-501-023 g in 1 PACKAGE; Type 0: Not a Combination Product01/08/2018
3NDC:51414-501-034 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2018
4NDC:51414-501-045 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2018
5NDC:51414-501-056 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2018
6NDC:51414-501-067 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2018
7NDC:51414-501-078 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2018
8NDC:51414-501-089 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2018
9NDC:51414-501-0910 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2018
10NDC:51414-501-1015 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2018
11NDC:51414-501-1120 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2018
12NDC:51414-501-1225 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2018
13NDC:51414-501-1330 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2018
14NDC:51414-501-1435 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2018
15NDC:51414-501-1540 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2018
16NDC:51414-501-1645 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2018
17NDC:51414-501-1750 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/12/201210/12/2012
Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)
Establishment
NameAddressID/FEIBusiness Operations
Yuyao Jessie Commodity Co.,Ltd.529892305manufacture(51414-501)

Revised: 4/2019
Document Id: 873286a0-b064-4d8a-e053-2a91aa0a5876
Set id: 6259609f-8625-1472-e053-2991aa0a10a2
Version: 2
Effective Time: 20190423
 
Yuyao Jessie Commodity Co.,Ltd.