Label: 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 May 26, 2020

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  • Active Ingredient(s)

    Alcohol75%v/v

  • Purpose

    Antiseptic

  • Use

    Use for hand disinfecting and cleaning when soap and water are not availableI.

  • 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

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

  • 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 a Poison Control Center right away

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry.
    Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

    STORAGE AND HANDLING SECTION
    Store between 15-30°C(59-86F).
    Avoid freezing and excessive heat above 40°C(104F).

  • Inactive ingredients

    Water

  • Package Label - Principal Display Panel

    3080508100

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78293-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 a
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78293-006-018 a in 1 BAG; Type 0: Not a Combination Product03/30/2020
    2NDC:78293-006-0230 a in 1 BAG; Type 0: Not a Combination Product03/30/2020
    3NDC:78293-006-0350 a in 1 BAG; Type 0: Not a Combination Product03/30/2020
    4NDC:78293-006-0480 a in 1 BAG; Type 0: Not a Combination Product03/30/2020
    5NDC:78293-006-05100 a in 1 BAG; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Guangdong Bolicen Bio-Technology Co., Ltd. (554525110)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Bolicen Bio-Technology Co., Ltd.554525110manufacture(78293-006)
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