Label: SANITIZING WIPES 70 PERCENT- ethyl alcohol solution

  • 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 November 29, 2020

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 70% V/V

  • PURPOSE

    ANTISEPTIC

  • USES

    HAND SANITIZER 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 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

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • OTHER SAFETY INFORMATION

    DISCARD USED WIPES IMMEDIATELY TO PREVENT CROSS CONTAMINATION.

  • DIRECTIONS

    • WIPE ALL AREAS OF HANDS UNTIL THEY ARE VISIBLY CLEAN. USE ONE OR MORE WIPES AND DISPOSE IN AN APPROPRIATE TRASH CONTAINER. LET HANDS AIR DRY.

  • OTHER INFORMATION

    • STORE BETWEEN 15-30C (59-86F)
    • AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40C (104F)
  • INACTIVE INGREDIENTS

    AQUA, GLYCERIN, PANTHENOL, FRAGRANCE.

  • QUESTIONS?

    CALL TOLL-FREE 1-866-942-9598 OR VISIT WWW.SANI-X.COM

  • PRINCIPAL DISPLAY PANEL

    01b LBL_freedom wipe_single_Front

    01b LBL_freedom wipe_single_back

  • INGREDIENTS AND APPEARANCE
    SANITIZING WIPES  70 PERCENT
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43219-101
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43219-101-013 mL in 1 POUCH; Type 0: Not a Combination Product05/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/06/2020
    Labeler - Emilia Cosmetics Ltd (600076624)
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