Label: ANTISEPTIC WIPES- ethyl 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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  • Active ingredients

    Ethyl Alcohol 62%........ Antiseptic

  • Purpose

    Antiseptic

  • Use

    Decresases bacteria on skin

  • Warnings

    For external use only

  • Do Not Use

    Do not use if you are allegic to any of the ingredients.

  • When using this product 

    When using this product do not use in or near eyes.

    In cases of contact, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if

    Stop use and ask a doctor if irritation or redness develops and continues 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:

    • Adults and children over 2 yeas of age:Apply to hands. Allow to dry without wioing.
    • Children under 2 year of age:ask doctor before use
  • Inactive ingredients

    Aloe barbadensis Extract, Fragrance, Glycerin, Lactic Acid, Water

  • principal display panel

    alcohol

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC WIPES 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72308-029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72308-029-1818 in 1 PACKAGE08/03/2020
    162 mg in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/03/2020
    Labeler - Flex Beauty Labs (080858917)
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