Label: REVITALIZE SPORTS HAND SANITIZER- ethyl alcohol gel

  • 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 December 18, 2020

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  • DRUG FACTS

  • Active ingredient:

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Use(s):

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

  • Warning:

    For external use only. Flammable, Keep from heat and flame.

    Do not use • on infants • 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 maybe signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    Apply as needed into the palm of hand and thoroughly spread on both hands, rub until dry. Supervise children under 6 years of age when using product.

  • Ingredients

    Water, Glycerin, Carbomer 980, Triethanolamine

    IMAGE

  • SPL UNCLASSIFIED SECTION

    Kills 99.9% of germs

    Manufactured by:

    Revive Sports, Inc.
    PO Box 423
    Hurricane WV 25526
    www.RevitalizeSports.com

    A FDA Registered Facility

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    REVITALIZE SPORTS HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81250-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81250-080-944 mL in 1 BOTTLE; Type 0: Not a Combination Product12/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/18/2020
    Labeler - Revive Sports Inc. (081044261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Revive Sports Inc.081044261manufacture(81250-080)
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