Label: FOAMING SANITIZING HAND- alcohol soap

  • NDC Code(s): 50865-710-17, 50865-710-41, 50865-710-44, 50865-710-55, view more
    50865-710-91
  • Packager: Kutol Products Company
  • 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 August 18, 2023

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 72% v/v

  • PURPOSE

    Purpose

    Antibacterial

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, contact a physician or poison control center. 

  • INDICATIONS & USAGE

    Uses Hand sanitizer to help reduce bacteria on the skin that could cause disease.

  • DOSAGE & ADMINISTRATION

    Directions To decrease bacteria on skin, apply small amount to palm. Briskly rub, covering hands with product until dry.

  • WARNINGS

    Warnings

    For external use only.

    FLAMMABLE. Keep away from heat or flames.

    Avoid contact with eyes. If eye contact occurs, flush eyes with water.

    Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    water,  cocamidopropyl PG-dimonium chloride phosphate,cocamidopropyl betaine, PEG-6 cocamide, laurtrimonium chloride, iodopropynyl butylcarbamate,methylisothiazolinone.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FOAMING SANITIZING HAND 
    alcohol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-710
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.072 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50865-710-411000 mL in 1 BAG; Type 0: Not a Combination Product12/01/2015
    2NDC:50865-710-1750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2015
    3NDC:50865-710-441000 mL in 1 BAG; Type 0: Not a Combination Product10/01/2015
    4NDC:50865-710-551200 mL in 1 BAG; Type 0: Not a Combination Product10/01/2015
    5NDC:50865-710-91532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/01/2015
    Labeler - Kutol Products Company (004236139)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(50865-710)
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!