Label: SUAVE HAND SANITIZER PROFESSIONAL- 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 November 4, 2020

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  • ACTIVE INGREDIENT

    Ethyl alcohol 75% v/v

  • PURPOSE

    ANTISEPTIC

  • USE

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • WARNINGS

    For External Use only. Highly flammable liquid and vapour. Keep away from/do not spray near heat, hot surfaces, sparks, electrical appliances, open flames and other ignition sources. Do not store in car. No smoking. Keep containers tightly closed.

    Do Not Use

    • On children less than 2 months of age
    • On open skin wounds

    When using this product keep out of eyes, ears, and mouth. In case of contact, rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Causes serious eye irritation. If swallowed, get medical help or contact Poison Control Center right away.

  • DIRECTIONS

    • Wet hands thoroughly with product and rub lightly until dry. Do not wipe off or rinse.

  • OTHER INFORMATION

    • Store between 15-30ºC (59-86ºF)
    • Avoid freezing and excessive heat above 40ºC (104ºF)
  • INACTIVE INGREDIENTS

    Acrylates Copolymer, Aminomethyl Propanol, Denatonium Benzoate, Glycerin, Purified Water USP, Tert-butyl Alcohol, Triethanolamine

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Suave_Hand Sani Gel_75pct_5000mL

    01b LBL_Suave_Hand Sani Gel_75pct_50mL

  • INGREDIENTS AND APPEARANCE
    SUAVE HAND SANITIZER PROFESSIONAL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50069-110(NDC:73931-018)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50069-110-115000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/25/2020
    2NDC:50069-110-1250 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/25/2020
    Labeler - UNILEVER ASIA PRIVATE LIMITED (894632699)
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