AMERFRESH ANTIBACTERIAL UNWRAPPED- alcohol soap 
Jiangsu Aimeili Cosmetic 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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77573-008 Charm_Tex unwrapped Antibacterial Soap

Active Ingredient

Benzethonium Chloride 0.1%

Purpose

Antibacterial

Use

For washing to decrease bacteria on skin

Warnings

For external use only

Do not use this product on infants under 6

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet bar with water

Lather vigorously and wash skin

Rinse and dry thoroughly

Inactive ingredients

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

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AMERFRESH ANTIBACTERIAL UNWRAPPED 
alcohol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77573-008
Route of AdministrationTOPICAL
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)  
WATER (UNII: 059QF0KO0R)  
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
PALM ACID (UNII: B6G0Y5Z616)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCONUT ACID (UNII: 40U37V505D)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77573-008-01200 in 1 CARTON10/27/2020
110 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2NDC:77573-008-02200 in 1 CARTON10/27/2020
268 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/27/2020
Labeler - Jiangsu Aimeili Cosmetic Co.,Ltd. (543903077)
Establishment
NameAddressID/FEIBusiness Operations
Jiangsu Aimeili Cosmetic Co.,Ltd.543903077manufacture(77573-008)

Revised: 4/2022
Document Id: ddc323c4-f79f-a7f4-e053-2995a90af319
Set id: 09432dc3-536a-47fc-8afc-1db2e2a622fe
Version: 2
Effective Time: 20220428
 
Jiangsu Aimeili Cosmetic Co.,Ltd.