Label: SURE WELL HAND SANITIZER (ETHANOL)- 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 June 25, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 68%

  • Purpose

    Antiseptic

  • Uses

    Decrease bacteria on hands
    Recommended for repeated use.

  • Warnings

    For external use only.

    Flammable - Keep away from fire or flame

  • When using this product

    avoid contact with eyes.

    if contact occurs, rinse thoroughly with waterr

  • Stop use and ask a doctor

    if irritation and redness develop or increase.

  • Keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply a small amount onto hands and rub briskly until dry.
    • Supervise children in the use of this product.
  • Other information

    • Read the directions and warnings before use.
    • Do not use for other purposes.
    • Store at 1-30℃ (33.8-86℉).
  • Inactive ingredients

    Water, Glycerin, Carbomer, Triethanolamine

  • Package Label - Principal Display Panel

    500 mL NDC: 73330-0016-1

    500ml_Label

  • INGREDIENTS AND APPEARANCE
    SURE WELL HAND SANITIZER (ETHANOL) 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73330-0016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.68 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73330-0016-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - COSNINE, Inc. (694607163)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSNINE, INC.694607163manufacture(73330-0016)
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