Label: SIMPLY SAFER DISINFECTANT WIPE- 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 July 30, 2020

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  • Active Ingredient(s)

    Alcohol 75% Purpose: Antiseptic

  • Purpose

    Antiseptic, wipes

  • Uses

    For handwashing to decrease bacteria on the skin.

  • Directions

    • Open label, remove wipe, and unfold
    • Wet hands thoroughly with product and allow to dry without wiping
  • Warnings

    For external use only. Do not use in the eyes. Do not flush.

  • STOP USE

    Discontinue use if irritation and redness develops. If condition persists for more than 72 hours, consult a doctor.

  • 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.

  • Other information

    • Store below 95F (35C)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    BENZALKONIUM CHLORIDE, WATER, CETYLPYRIDINIUM CHLORIDE, DIDECYLDIMONIUM CHLORIDE, PHENOXYETHANOL, GLYCERIN, N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14)

  • Package Label - Principal Display Panel

    1PC NDC: 79754-002-01

    PDP

  • INGREDIENTS AND APPEARANCE
    SIMPLY SAFER DISINFECTANT WIPE 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79754-002(NDC:40562-011)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) (UNII: G258TFN61X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79754-002-011 in 1 BAG07/23/2020
    16 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 finalpart333A07/23/2020
    Labeler - Simply Safer Products Llc (117579462)