Label: MEDAMA FOAM HAND SANITIZER- ethanol liquid

  • NDC Code(s): 81776-204-01
  • Packager: Ace Janitorial Supply co., Inc.
  • 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 September 26, 2022

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 70% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • For handwashing to decrease bacteria on the skin after changing diapers, assisting ill persons, or before contact with a person under medical care or treatment.
    • Recommended for repeated use.

  • WARNINGS

    Warnings

    • For external use only.

    • Keep out of eyes, ears, or mouth.

    • Discontinue use if irritation occurs.

    • Keep out of reach of children.

    FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

  • DOSAGE & ADMINISTRATION

    Directions

    • If hands are visibly soiled, wash with soap and water and dry hands.
    • Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.
  • Inactive ingredients

    benzalkonium chloride, chlorhexidine gluconate, isopropyl alcohol, PEG 10 dimethicone, PEG-14M, phenoxyethanol, polyquaternium 10, water.

  • SPL UNCLASSIFIED SECTION

    Medama Solutions

    1365 62st Street, Brooklyn, New York, 11219

    P 718.492.7200 • F 718.492.3878

    MADE IN THE USA

  • PRINCIPAL DISPLAY PANEL

    MEDAMA

    Waterless Foam Hand Sanitizer

    1000 ml

    Medama Single Label

  • INGREDIENTS AND APPEARANCE
    MEDAMA FOAM HAND SANITIZER 
    ethanol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81776-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE OXIDE 600000 (UNII: 2126FD486L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81776-204-011000 mL in 1 CONTAINER; Type 0: Not a Combination Product04/13/202107/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/13/202107/31/2024
    Labeler - Ace Janitorial Supply co., Inc. (080453756)
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!