Label: 70% ALCOHOL WET WIPES- isopropyl 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 14, 2020

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  • Active Ingredient(s)

    Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antibacterial Antiseptic Wet Wipes

  • Use

    Sanitizes and decreases bacteria on 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

    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 develops and continues for more than 72 hours. 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 at 1-800-222-1222

  • Directions for use

    adults and children 2 years and over - Apply to hands , wet hands thoroughly with product and allow it to dry

    children under 2 years - ask a doctor before use

    - to dispense peel back front label slowly remove wipes

    - to reseal pouch firmly run thumb over the label

    - dont flush

  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat
  • Inactive ingredients

    water, glycerine, tocopheryl acetate ( vitamin E) panthenol

  • Package Label - Principal Display Panel

    wipes48 pcs Wipes NDC: 81214-260-48

  • INGREDIENTS AND APPEARANCE
    70% ALCOHOL WET WIPES 
    isopropyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81214-260
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.01 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.8 mL  in 100 mL
    PANTHENOL (UNII: WV9CM0O67Z) 0.01 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 29.18 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81214-260-48260 mL in 1 POUCH; Type 0: Not a Combination Product11/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/01/2020
    Labeler - PRISTINE MK LLC (117674251)
    Registrant - FRESH CO COSMETICS SH.P,K (499428868)
    Establishment
    NameAddressID/FEIBusiness Operations
    FRESH CO COSMETICS SH.P.K499428868manufacture(81214-260)
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