Label: AMERFRESH ANTIBACTERIAL UNWRAPPED- alcohol soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated April 28, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • 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

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

  • KEEP OUT OF REACH OF CHILDREN

    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

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!