Label: A1 AMERICAN DEFENDER COLLECTION- alcohol cloth

  • 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 December 27, 2022

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  • Active Ingredient(s)

    Alcohol 75 % v/v. 

  • Purpose

    Antiseptic

  • Uses

    For hand washing to decrease bacteria on the skin.

    Apply topically to the skin to help prevent cross contamination

  • Warnings

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

    When using this product  do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Tear open packet

    Open and unfold wipe

    Thoroughly wipe hands, fingers and wrists

    Discard after

    single use

  • STORAGE AND HANDLING

  • Inactive ingredient

    Water 

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    A1 AMERICAN DEFENDER COLLECTION 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78940-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78940-003-011 in 1 PACKAGE07/15/2020
    12 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:78940-003-025 in 1 PACKAGE07/15/2020
    22 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:78940-003-0310 in 1 PACKAGE07/15/2020
    32 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:78940-003-0425 in 1 PACKAGE07/15/2020
    42 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:78940-003-0580 in 1 CANISTER07/15/2020
    52 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/2020
    Labeler - Tiger Hospitality, LLC dba A1 American (021848056)
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