Label: GENTLEHANDS ANTISEPTIC HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 10, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70%

  • Purpose

    Antiseptic

  • Use

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use
    • for use when soap and water are not available

  • Warnings

    Flammable, keep away from fire/flame

    For external us e only

    Do not use

    • in children less than 2 months of age

    • open skin wounds

    When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water 

    Stop use and ask a doctor if

    • irritation and redness develop

    • condition 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.

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping
    • supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    • store between 15-30˚C (59-86˚F)
    • avoid freezing and excessive heat above 40˚C (104˚F)

  • Inactive ingredients


    carbomer, EDTA, glycerol, polysorbate, triethanolamine, water

  • Questions? +1-786-843-1308

    You may also report serious side effects to this phone number. Mon - Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    LOT NO. AND EXPIRY

    PRINTED ON BOTTLE

    Distributed by: Roldan Industries

    1500 E Tropicana Ave. Ste 154 Las Vegas NV 89119

    COUNTRY OF ORIGIN: MEXICO

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    GENTLEHANDS ANTISEPTIC HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79109-700
    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
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79109-700-222 mL in 1 POUCH; Type 0: Not a Combination Product08/01/2020
    2NDC:79109-700-0660 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    3NDC:79109-700-11120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    4NDC:79109-700-12125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    5NDC:79109-700-25250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    6NDC:79109-700-50500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    7NDC:79109-700-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    8NDC:79109-700-373785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2020
    Labeler - ROLDAN INDUSTRIES (117553465)
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