Label: ALCOHOL FOAMING HAND SANITIZER  - alcohol liquid 

  • Label RSS
  • NDC Code(s): 42961-005-02, 42961-005-05, 42961-005-06
  • Packager: Cintas Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/14

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  • ACTIVE INGREDIENT

    Active ingredient                               

    Ethyl Alcohol 62%

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  • INDICATIONS & USAGE

    Uses

    For hand sanitizing to decrease bacteria on the skin

    Recommended for repeated use

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  • WARNINGS

    Warnings

    Flammable. Keep away from fire or flames.

    For external use only.

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

    Stop use and ask a doctor if irritation or redness develops, or if conditions persists for more than 72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION

    Directions:

    Wash hands with soap and water

    Rinse with potable water

    Pump a small amount of foam into palm of hand

    Rub thoroughly over all surfaces of both hands

    Rub hands together briskly until dry

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  • STORAGE AND HANDLING

    Other Information:

    Store below 110 F (43 C)

    May discolor certain fabrics or surfaces

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  • PRINCIPAL DISPLAY PANEL

    Sanis

    Alcohol Foaming

    Hand

    Sanitizer

    800 ML 27.0 FL OZ

    container label

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  • INACTIVE INGREDIENT

    Inactive ingredient

    DEA-C8-18 perfluoroalkylethyl phosphate, Glycerin, Isopropyl alcohol, Water

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  • PURPOSE

    Purpose

    Antimicrobial

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  • INGREDIENTS AND APPEARANCE
    ALCOHOL FOAMING HAND SANITIZER  
    alcohol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42961-005
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Alcohol (Alcohol) Alcohol 62 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Glycerin  
    ISOPROPYL ALCOHOL  
    DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42961-005-02 800 mL in 1 BOTTLE, PLASTIC
    2 NDC:42961-005-06 50 mL in 1 BOTTLE, PLASTIC
    3 NDC:42961-005-05 500 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/01/2009
    Labeler - Cintas Corp. (056481716)
    Establishment
    Name Address ID/FEI Business Operations
    Natural Essentials Incorporated 947484713 manufacture(42961-005)
    Establishment
    Name Address ID/FEI Business Operations
    Avmor 202107827 manufacture(42961-005)
    Establishment
    Name Address ID/FEI Business Operations
    Best Sanitizers, Inc 627278224 manufacture(42961-005)
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