AMERFRESH ANTIBACTERIAL- benzethonium chloride soap 
Yangzhou Tracey Daily Chemical Plastic 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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73343 004 AMERFRESH Antibacterial SOAP (0.1%Benzethonium chloride)

Drug Facts

Active Ingredient

Benzethonium Chloride 0.1%

Purpose

Antibacterial

Uses

For washing to decrease bacteria on skin.

Warnings

For External Use Only.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Do not use this product on infants under 6.

Keep out of reach of children.

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

Directions

Inactive Ingredients

Soap (Sodium Palmate and/or Sodiun Tallowate. Sodium Cocoate and/or Sodium Palm Kernelate) Water, Palm Acid, Glycerin, Sodium Chloride, Coconut Acid,Fragrance, Tetrasodium EDTA, Citric Acid Anhydrous.

1

AMERFRESH ANTIBACTERIAL 
benzethonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73343-004
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM PALMATE (UNII: S0A6004K3Z)  
COCONUT ACID (UNII: 40U37V505D)  
PALM ACID (UNII: B6G0Y5Z616)  
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73343-004-011 in 1 CASE08/15/2020
185 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/15/2020
Labeler - Yangzhou Tracey Daily Chemical Plastic Co., Ltd. (560398069)
Establishment
NameAddressID/FEIBusiness Operations
Yangzhou Tracey Daily Chemical Plastic Co Ltd560398069manufacture(73343-004)

Revised: 8/2020
Document Id: ad07d9cb-9364-78cd-e053-2a95a90abc4c
Set id: ad07d9cb-9363-78cd-e053-2a95a90abc4c
Version: 1
Effective Time: 20200816
 
Yangzhou Tracey Daily Chemical Plastic Co., Ltd.