Label: PURE CARE HOUSEHOLD WIPES- isopropyl alcohol 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 September 30, 2020

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  • ACTIVE INGREDIENT

    Isopropyl Alcohol 75%

    Antiseptic

  • USE

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

  • Warning

    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 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
    lf irritation or rash occurs. These may be sign of a serious condition.

    lf 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

  • Inactive ingredients

    Purified water

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    PURE CARE HOUSEHOLD WIPES 
    isopropyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78536-006
    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:78536-006-0518 in 1 CARTON09/30/2020
    1140 in 1 PAIL
    1697.9 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    2NDC:78536-006-0324 in 1 CARTON09/30/2020
    280 in 1 PAIL
    2398.8 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    3NDC:78536-006-0424 in 1 CARTON09/30/2020
    3100 in 1 PAIL
    3498.5 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    4NDC:78536-006-0224 in 1 CARTON09/30/2020
    470 in 1 PAIL
    4349 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    5NDC:78536-006-0124 in 1 CARTON09/30/2020
    5100 in 1 BAG
    5498.5 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/30/2020
    Labeler - Zhejiang Yiwu Mingou Biotechnology Co., Ltd. (554535538)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Yiwu Mingou Biotechnology Co., Ltd.554535538manufacture(78536-006)
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