Label: HAND SANITIZER- 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 July 28, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer wipes

  • Use

    Hand Sanitizer wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

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

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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

    • . Rub hands together until dry. disponse properly.
    • Supervise children under 6 years of age when using this product.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    water,Glycerin, Polyethylene glycol, Isopropyl myristate

  • Package Label - Principal Display Panel

    210 ML NDC 79337-157-01 wipes bag

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79337-157
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) 0.37 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.68 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 28.46 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.49 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79337-157-01210 mL in 1 BAG; Type 0: Not a Combination Product07/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - ORGANIKISIMO SA DE CV (951579669)
    Registrant - ORGANIKISIMO SA DE CV (951579669)
    Establishment
    NameAddressID/FEIBusiness Operations
    ORGANIKISIMO SA DE CV951579669manufacture(79337-157)
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