Label: ATTIPURE HAND SANITIZER GEL- 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 2, 2020

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  • Active ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antimicrobial

  • Use

    For handwashing to decrease bacteria on skin without soap and water. Recommended for repeated use.

  • Warnings

    For external use only. Flammable, Keep away from fire or flame.

  • Do not use

    in eyes. If this happens, rinse thoroughly with water.

  • Stop use and ask a doctor

    if irritation and rash appears and lasts.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Wet hands & wrists thoroughly with product and allow to dry without wiping. Children under 6 years of age should be supervised while using this product.

  • Inactive ingredients

    Aqua(Purified Water), Aloe Vera, Allantoin, Scutellaria Baicalensis Root Extract, Carbomer, Glycerin

  • Package Label

    60ml NDC: 76709-203-01 Label

    500ml NDC: 76709-203-02 Label

  • INGREDIENTS AND APPEARANCE
    ATTIPURE HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76709-203
    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
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76709-203-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product07/03/2020
    2NDC:76709-203-02500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/03/2020
    Labeler - INVICTA ASIA CO., LTD (695625867)
    Registrant - INVICTA ASIA CO., LTD (695625867)
    Establishment
    NameAddressID/FEIBusiness Operations
    INVICTA ASIA CO., LTD695625867label(76709-203)
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