Label: JOYLUX ANTI BACTERIAL HAND SANITIZER- alcohol gel

  • NDC Code(s): 71734-301-01
  • Packager: JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.
  • 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 April 28, 2020

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  • Active Ingredient

    Ethyl Alcohol 62%

    Purpose

    Antiseptic

  • Uses

    Hand sanitizer to help decrease virus on the skin. When water, soap and towel are not available. Recommended for repeated use.

  • Warnings

    For external use only.

    Avoid contact with the wound. 

    Do not allow this produts to come into contact with eyes or nearby. If you accidentally touch a wound or eye, rinse immediately

    with water. If skin irritation or sensitivity occurs, discontinue use immediately and consult your doctor.

    Not recommended for infants. 

    When using this product

    Dn not allow children under 6 years of age to handle or apply, contact your doctor immediately.

    Keep out of reach of children.

    If swalllowed carelessly, contact your doctor immdiately.

    No water as needed. Apply a small amount of product to dry skin.

  • Inactive Ingredients

    Triethanolamine, Carbomer, Glycerine, Disodium EDTA, Pure Water

  • Product Labeling

    Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    JOYLUX ANTI BACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71734-301
    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
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 934 (UNII: Z135WT9208)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71734-301-015 mL in 1 DOSE PACK; Type 0: Not a Combination Product04/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/28/2020
    Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Registrant - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.544530534manufacture(71734-301)
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