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 August 4, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient(s)

    Ethyl Alcohol 75%

  • Purpose

    Antiseptic

  • Use

    1.Hand Sanitizer to help decrease bacteria on the skin.

    2.When water,soap & towel are not available.

    3.Recommended for repeated use.

  • Warnings

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

  • Do not use

    Do not apply around eyes.

    Do not use in ears & mouth.

  • WHEN USING

    When using this product avoid contact with eyes.In case of contact flush eyes with water.

  • STOP USE

    Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children must be supervised in use of this product.

  • Directions

    Tear off the package and pull out the cotton piece, wipe and disinfect the skin.

  • Other information

    Store at 20C (88 to 77F) may discolor fabrices.

  • Inactive ingredients

    Water, spunlaced nonwovens.

  • Package Label - Principal Display Panel

    label-1 wipe

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90059-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL750 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90059-001-015 mL in 1 PACKAGE; Type 0: Not a Combination Product08/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/05/2020
    Labeler - Qingdao Miuton Medical Co.,LTD. (544362883)
    Registrant - Qingdao Miuton Medical Co.,LTD. (544362883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Qingdao Miuton Medical Co.,LTD.544362883manufacture(90059-001)
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