Label: ALCOHOL WET WIPES- 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 September 28, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 75% (v/v)

    Purpose

    Antiseptic

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use
  • Warnings

    • For external use only
    • Flammable
    • Keep away from fire or flame

    Do not use

    • on children less than 2 months old
    • on open skin wounds

    When using this product

    • keep out of eyes, ears, In case of contact with eyes, flush thoroughly with water.
    • avoid contact with broken skin
    • do not inhale or ingest

    Stop use and ask a doctor if

    • irritation or redness develops
    • Condition persists for more than 72 hours

    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

    • Do not store above 105°F
    • May discolor some fabrics
    • Harmful to wood finishes and plastics
  • Inactive ingredients

    aminomethyl propanol, carbomer homopolymer, glycerin, propylene glycol, purified water USP

  • Package Labeling:50count

    Bottle3

  • Package Labeling:100count

    Bottle4

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WET WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74979-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74979-005-0150 in 1 CANISTER08/20/2020
    13.56 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:74979-005-02100 in 1 CANISTER08/20/2020
    23.56 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/20/2020
    Labeler - Robert Gordon Ind. Ltd. (070064709)
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