Label: ANTISEPTIC- alcohol gel

  • NDC Code(s): 72663-111-12, 72663-111-23
  • Packager: Welly Health PCB
  • 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 5, 2019

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  • SPL UNCLASSIFIED SECTION

    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

  • Principal Display Panel – Box Label

    OINTMENT REFILLS

    Welly FIRST AID

    Clean Hands
    INSTANT HAND SANITIZER

    COUNT 12

    NET WT 0.03 oz (0.9g)

    TOTAL NET WT 0.36 oz (10.8g)

    Ethyl Alcohol

    Principal Display Panel – Box Label
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol665 mL  in 1000 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:72663-111-1212 in 1 BOX08/27/2019
    1NDC:72663-111-230.9 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 PCB (116766884)
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