Label: AMER FRESH- benzalkonium chloride 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 November 10, 2020

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

View All Sections
  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antibacterial

  • Use

    For washing to decrease bacteria on the skin

  • Warnings

    For external use only.

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

    Stop use and doctor ask if irritation and redness develops

  • 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

    • Sodium Palmitate
    • Palm Kernelate
    • Fragrance
    • Aqua
    • Sodium Chloride
    • Glycerine
    • Titanium Di Oxide
    • Tetra Sodium EDTA

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    AMER FRESH 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80865-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALMITATE (UNII: JQ43KP6296)  
    PALM KERNEL OIL (UNII: B0S90M0233)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80865-001-0110 g in 1 POUCH; Type 0: Not a Combination Product11/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/10/2020
    Labeler - MRJ'S CROWN INDUSTRIES PRIVATE LIMITED (853186269)
    Establishment
    NameAddressID/FEIBusiness Operations
    MRJ'S CROWN INDUSTRIES PRIVATE LIMITED853186269manufacture(80865-001)
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!