Label: FOAMING MOUSSE HAND SANITIZER- alcohol aerosol, foam

  • 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 10, 2020

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

View All Sections
  • Active Ingredient

    Ethyl Alcohol 62% v/v

  • Purpose

    Antiseptic

  • Uses

    • To help decrease bact:eriafgerms on the sk!in that could cause

    disease. For use when soap and water are not available.

    • Recommended for repeated use.
  • Warnings

    Warnings
    For external use only

    • Do not puncture or incinerate.

    • Do not store above 120°F (49°C).

    When using this product

    • Avoid contact with eyes.
    • It splashed in eyes, rinse immediately and thoroughly with water.
    • Do not use on chil'dren under 2 months of age.
    • Do not use on open wounds.
    • Discontinue use if irritation/redness occurs.

    Stop use and ask a physician

    Stop use and ask a physician if irritation occurs for more than 3 days, contact a physician.

    Keep out of reach of children

    • In case of ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Shake well before using.
    • Spray product on hands, enough to cover all surfaces. Rub hands together until all surfaces are wet and fully covered. Continue rubbing untiil hands feel dry. Do not rinse or wipe off sanitizer.
    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • Dosage & Administration

    • Spray product on hands, enough to cover all surfaces. Rub hands together until all surfaces are wet and fully covered. Continue rubbing untiil hands feel dry. Do not rinse or wipe off sanitizer.

  • Other Information

    • For best benefit, store and use are 55-85° F (13-29°C).

  • Inactive Ingredient

    Water, Hydrofluorocarbon 152a, lsobutane, Emulsifying Wax., Cetyl Lactate, Steareth-2, Sodium Benzoate, Sodium Sesquicarbonate.
    Fragrance

  • Principal Display Panel

    200 mL NDC: 17630-3093-1

    Paya®

    HAND

    SANITIZER

    ANTISEPTIC

    FOAM

    62% v/v

    Ethyl alcohol*

    Fast-acting

    No Rinsing!

    Lightweight

    formula

    *Non-Sterile Solution.

    Net Wt: 7 oz (200g)

    41801PB label_V2

  • INGREDIENTS AND APPEARANCE
    FOAMING MOUSSE HAND SANITIZER 
    alcohol aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-3093
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17630-3093-11 mL in 1 BOTTLE; Type 0: Not a Combination Product03/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/20/2020
    Labeler - Accra Pac, Inc. (DBA KIK-Indiana) (024213616)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accra Pac, Inc. (DBA KIK-Indiana)024213616manufacture(17630-3093)
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!