Label: ALCOHOL 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 June 12, 2020

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  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Alcohol wipes

  • Use

    • For hand santitizing to decrease bacteria on the skin.
    • Apply topically to the skin to help prevent cross contamination.
    • Not recommended for repeated use.
    • Dries in seconds.

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

  • Do not use

    in or contact the eyes.

  • Stop use and ask a doctor

    if too much skin irritation and sensitivity develops or increases

  • 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

    • Gently pull back resealable label, remove and use wipe as required.
    • Reseal back after use to avoid evaporation of alcohol.
  • Other information

    • Store at room temperature 15-30℃ (59-86°F).
    • Lot No. Manufacture date and expiration date can be found on package.
  • Inactive ingredients

    water

  • Package Label - Principal Display Panel

    1 wipe NDC: 79060-001-01

    PDP

    10 wipes NDC: 79060-001-02

    PDP

    50 wipes NDC: 79060-001-03

    PDP

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79060-001(NDC:75162-1001)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79060-001-011 in 1 PACKAGE06/12/2020
    11.35 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:79060-001-0210 in 1 PACKAGE06/12/2020
    21.35 g in 1 PATCH; Type 0: Not a Combination Product
    3NDC:79060-001-0350 in 1 PACKAGE06/12/2020
    31.35 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/12/2020
    Labeler - Vara Home Usa Llc (802033196)
    Registrant - Shandong Mainclean Medical Products Co., Ltd. (418445935)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Mainclean Medical Products Co., Ltd.418445935manufacture(79060-001) , relabel(79060-001)
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