Label: WELLY CLEAN HANDS- alcohol gel

  • NDC Code(s): 72663-112-12, 72663-112-23
  • Packager: Welly Health PBC
  • 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 31, 2021

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 66.5%

  • Purpose

    Antiseptic

  • Uses

    • For handwashing to decrease bacteria on skin without soap and water
    • Recommended for repeated use
  • Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    Do not use in eyes. If this happens, rinse thoroughly with water

    Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours

    Keep this and all drugs out of the reach of children. If ingested get medical help or contact a Poison Control Center right away

  • Directions

    • Wet hands & wrists thoroughly with product and allow to dry without wiping
    • Children under 6 years of age should be supervised while using this product
  • Inactive Ingredients

    aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

  • SPL UNCLASSIFIED SECTION

    OINTMENT REFILLS

    Welly FIRST AID  Clean Hands INSTANT HAND SANITIZER

    Ethyl Alcohol

    Get the refills you need to build the Welly first aid kits you want.

    Keep hands clean when there's no sink in sight.

    Distributed by: Welly Health PBC

    Minneapolis, MN 55402

    1-833-BE-WELLY

    Welly TM     www.GetWelly.com

    Made in U.S.A

    RE19SAF

  • Packaging

    Label

  • INGREDIENTS AND APPEARANCE
    WELLY CLEAN HANDS 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL66.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72663-112-1212 in 1 BOX08/27/2019
    1NDC:72663-112-230.9 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/27/2019
    Labeler - Welly Health PBC (116766884)
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