Label: 75% ALCOHOL WIPES 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 March 28, 2022

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  • ACTIVE INGERDIENT

    Alcohol 75% by volume

  • PURPOSE

    Antimicrobial

  • USES

    Decreases bacteria on the skin

  • WARNINGS

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

    Do not use
    in children less than 2 months of age
    on open skin wounds

    When using this product keep out of eyes, ears, and mouth.
    In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • DO NOT USE

    in children less than 2 months of age
    on open skin wounds

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth.
    In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    Open package. Pull wipe. Close package to retain moisture
    Wet hands thoroughly with product.
    Allow to dry without rinsing

  • OTHER INFORMATION

    Store between 15-30C (59-86F)
    Avoid freezing and exessive heat aboce 40C (104F)

  • INACTIVE INGERDIENTS

    Water

  • Package Label - Principal Display Panel

    74763-018-03 80P bag74763-018-04 80P Cannister74763-018-05 100P bag74763-018-01 80P74763-018-02 100P

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL WIPES 
    75% alcohol wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74763-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74763-018-0180 in 1 CANISTER; Type 0: Not a Combination Product04/30/2020
    2NDC:74763-018-02100 in 1 CANISTER; Type 0: Not a Combination Product04/30/2020
    3NDC:74763-018-0380 in 1 BAG; Type 0: Not a Combination Product04/30/2020
    4NDC:74763-018-0480 in 1 CANISTER; Type 0: Not a Combination Product04/30/2020
    5NDC:74763-018-05100 in 1 BAG; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/30/2020
    Labeler - ZHEJIANG GAFLE AUTO CHEMICAL CO.,LTD (550707836)
    Registrant - ZHEJIANG GAFLE AUTO CHEMICAL CO.,LTD (550707836)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHEJIANG GAFLE AUTO CHEMICAL CO.,LTD550707836manufacture(74763-018)
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