Label: ALCOHOL HAND SANITIZER- hand sanitizer 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 April 17, 2020

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  • ACTIVE INGREDIENT

    Alcohol 75% v/v. Purpose: Antiseptic

  • PURPOSE

    Antiseptic, Hand Sanitizer

  • INDICATIONS & USAGE

    Hand sanitizer to help reduce bacteria on the skin. Recommend for repeated use.

  • WARNINGS

    For external use only.

    Flammable. Keep away from heat or flame.

  • WHEN USING

    Keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

  • STOP USE

    Stop use and ask a doctor if irritation develop, persisit for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children. If sallowed, get medical help right away.

  • DOSAGE & ADMINISTRATION

    Place enough product on hands to cover hands and rub hands quickly until dry. Children under 6 years of age should be supervised when using product.

  • OTHER SAFETY INFORMATION

    Do not store above 105F (43F). May discolor certain fabrics or surfaces.

  • INACTIVE INGREDIENT

    Aqua, Hydrolyzed Jojoba Esters, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Aloe Barbadensis Leaf Juice Powder, Citric Acid

  • PRINCIPAL DISPLAY PANEL

    55450-005-01 100g

    PDP

  • INGREDIENTS AND APPEARANCE
    ALCOHOL HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55450-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55450-005-01100 g in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/17/2020
    Labeler - Shantou Shengmei Biotechnology Co., Ltd. (554528509)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shantou Shengmei Biotechnology Co., Ltd.554528509manufacture(55450-005)
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