Label: PURE CARE -ALCOHOL WIPES cloth

  • Category: HUMAN OTC DRUG LABEL

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 10, 2020

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  • Active Ingredient(s)

    Isopropyl alcohol 75% v/v

  • Purpose

    Antiseptic

  • Use

    Wipe surface to help reduce bacteria that can potentially cause disease.

  • Warnings

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

  • Do not use

    • In children less than 2 month 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 with water.

  • STOP USE

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

  • 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

    • Remove and unfold wipe
    • Wipe surface thoroughly
    • Dispose of used wipe in trash, do not flush
  • Other information

    • Store between 50-86℉(15-30℃)
    • Avoid freezing and excessive heat above 104℉(40℃)
  • Inactive ingredients

    Purified water

  • Package Label - Principal Display Panel

    100pcs NDC: 54016-020-12 100pcs label_1100pcs label_2

  • INGREDIENTS AND APPEARANCE
    PURE CARE -ALCOHOL WIPES 
    pure care -alcohol wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54016-020
    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
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54016-020-12100 in 1 PACKET12/10/2020
    15.5 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/10/2020
    Labeler - Jinhua Huihuang Non-woven Products Co., Ltd. (540165729)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jinhua Huihuang Non-woven Products Co., Ltd.540165729manufacture(54016-020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gourmet Home Products, LLC962068677label(54016-020)
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