Label: INSTANT 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 July 14, 2020

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  • Drug Facts

  • Active ingredients

    Ethyl / Alcohol 75% v/v

    Purpose

    Antiseptic

  • Uses

    • Hand sanitizer to help decrease bacterial on the skin, when water, soap & towel are not available.
    • Recommended for repeated use.
  • Warnings

    For external use only. Flamable. Keep away from fire or flame.

    Do not apply around eyes.

    Do not use

    Do not use in ears & mouth.

    When using product,

    Avoid contact with eyes. In case of contact flush eyes with water.

    Stop use and ask a doctor

    if redness or irritation develop and persists for more than 72 hours.

    Keep out of reach of children.

    Children must be supervised in use of htis product.

  • Directions

    • Place enough product into your palms and thoroughly spread on both hands.
    • Rub into skin until dry.
  • Other information

    • Store below 110 °F (43 °C).
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Glycerin, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer Fragrance Aminomethyl Propanol, Propylene Glycol, Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Lactic Acid, Citric acid.

  • Package Labeling

    Label

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78303-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ETHYLENE GLYCOL (UNII: FC72KVT52F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78303-003-003785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/15/2020
    Labeler - SBU GROUP L.P.DBA APOLLO DISTRIBUTORS (841530095)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aogrand International Trade Corporation421353092manufacture(78303-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU XUELEI COSMETIC CO LTD526885026manufacture(78303-003)
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