Label: ANTIBACTERIAL 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 January 4, 2022

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  • Warnings

    For external use only. Flammable

  • DO NOT USE

    Do not use on children less than 2 month of age. Do not use on open skin wounds.

  • ASK DOCTOR

    Stop use and ask doctor if redeness or irritation develop and persist for more than 72 hours

  • STOP USE

    Stop use and ask doctor if redenss or irritation develop and persist for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • STORAGE AND HANDLING

    Store at 20 C (68-77 F). May discolore fabrics

  • Purpose

    Antiseptic

  • Directions

    Squeeze enough product on hands to cover all surfaces. Rub hands together untill dry.

  • OTHER SAFETY INFORMATION

    Keep away from heat and flame. Keep out of eyes, ears, and mouth.

  • INDICATIONS & USAGE

    Squezze enough product on hands to cover all surfaces. Rub hands together untill dry.

  • Active Ingridient

    Ethyl Alcohol 62%

  • Inactive Ingridient section

    Trolamine. Water. Propylene Glycol. Aloe Vera. Carbomer. Glycerine.

  • PRINCIPAL DISPLAY PANEL

    Antibacterial Hand Sanitizer Gel

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70445-416
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70445-416-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product10/16/2020
    2NDC:70445-416-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product10/16/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/16/2020
    Labeler - Webb Business Promotions, Inc (154445647)
    Registrant - Webb Business Promotions, Inc (154445647)
    Establishment
    NameAddressID/FEIBusiness Operations
    Webb Business Promotions,Inc154445647label(70445-416) , manufacture(70445-416) , relabel(70445-416) , repack(70445-416)
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