Label: HAND SANITIZER- alcohol gel

  • 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 May 19, 2020

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  • SPL UNCLASSIFIED SECTION

    Water 24.19%, Alcohol 70%, Carbomer 0.4%, Triethanolamine 0.4%, Glycerin 2%, Propylene Glycol 0.5%

    ,Aloe Barbadensis Leaf Juice 2%, Tocopheryl Acetate 0.5%, Fragrance 0.01%

  • Active Ingredient(s)

    Alcohol Denat 70.0%
    Purpose: Antimicrobial

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    To decrease bacteria on the skin. Recommended for repeated use.

  • Warnings

    Supervision required for children under the age of 10. For external use only. Flammable. Keep away from heat and flames.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    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. Briskly rub hands together for 10 seconds - wait for air dry.

  • Other information

    Store in a cool dry place at room temperature.

  • Inactive ingredients

    water, carbomer, triethanoglamine, glycerine, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate.

  • Package Label - Principal Display Panel

    480 mL NDC: 78098-001-02 480ml-2

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78098-002
    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
    TROLAMINE (UNII: 9O3K93S3TK) 0.4 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 2 mL  in 100 mL
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.5 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) 0.4 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.5 mL  in 100 mL
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.01 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78098-002-01480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - GUANGZHOU NODA PHARMACEUTICAL TECHNOLOGY INCORPORATED CO., LTD (554457375)
    Registrant - GUANGZHOU NODA PHARMACEUTICAL TECHNOLOGY INCORPORATED CO., LTD (554457375)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU NODA PHARMACEUTICAL TECHNOLOGY INCORPORATED CO., LTD554457375manufacture(78098-002)
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