Label: DEFENSE AG HAND SANITIZER- ipa 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 September 25, 2020

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  • Active Ingredient(s)

    Isopropyl Alcohol 75% v/v. Antiseptic to help reduce bacteria that potentially can cause disease

  • Inactive ingredients

    Ultra Pure Water, Hydroxyethyl Cellulose, Curcumin

  • Purpose

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

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are unavailable.

  • Warnings

    Keep away form fire and flame.
    Flammable
    For external use on hands only.
    Keep out of eye, ears and mouth.
    If contact in eyes, flush thoroughly with water.
    Keep out of reach of children.
    If swallowed seek medical help immediately or call your poison control center.
    Store between 15-30 (58-86F)
    Avoid freezing and excessive heat above 40C (104F)
    Will damage wood finishes, plastics and some fabrics.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • KEEP OUT OF REACH OF CHILDREN

    Adult supervision recommended for children under 6 years old.

  • Directions

    Dosage: Place enough product on hands to cover all surfaces. Rub hands together until dry.

    Administration: Topical

  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Package Label - Principal Display Panel

    8 oz label4 oz label16 oz label1 Gal label

  • INGREDIENTS AND APPEARANCE
    DEFENSE AG HAND SANITIZER 
    ipa hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79930-7105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) 0.2 mL  in 100 mL
    CURCUMIN (UNII: IT942ZTH98) 1.3 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Coloryellow (light translucent yellow hint) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79930-7105-1100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/30/2020
    2NDC:79930-7105-2250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/30/2020
    3NDC:79930-7105-3350 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/30/2020
    4NDC:79930-7105-4500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/30/2020
    5NDC:79930-7105-53785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/25/2020
    Labeler - Nexderma (079533940)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nexderma079533940manufacture(79930-7105) , pack(79930-7105) , label(79930-7105)
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