Label: SWEET SKIN ETC HAND SANITIZER WIPES- benzalkonium chloride cloth

  • 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 October 30, 2020

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  • Drug Facts

  • Active ingredients

    Benzalkonium Chloride 0.10%

  • Purpose

    Antiseptic

  • Indications and usage

    • For hand washing to decrease bacteria on the skin. 

      Recommended for repeat use.

  • Warnings

    • For external use only.

    • Keep out of reach of eyes. If contact occurs, rinse thoroughly with water.

    • Do not use if you are allergic to any one of the ingredients.

    • Discontinue use if irritation or redness develops, and if condition persists for more than 72 hours consult a physician.

    • Keep out of reach of children unless under adult supervision.

    • If swallowed, get medical help.

  • Directions of use

    • Wet hands thoroughly with product and allow to dry without rinse.

    • Children under six years of age should be supervised when using this product.

  • Other Information

    • Store in a dry place away from fire.

  • Inactive Ingredients

    • Water (Aqua), Glycerol, Propanediol, Aloe Vera Extract, IPBC, Amino acid moisturizer, Vitamin E, Citric acid, Hexadecyl Pyridinium Chloride, Dodecyl polyglucoside.

  • SPL UNCLASSIFIED SECTION

    ALCOHOL FREE

    DISTRIBUTED BY

    Sweet Skin Etc. , LLC.

    Prairieville, LA 70769

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    SWEET SKIN ETC HAND SANITIZER WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79891-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    BETAINE (UNII: 3SCV180C9W)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79891-002-011 in 1 BAG10/30/2020
    13 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/30/2020
    Labeler - DOBOLV (QUANZHOU) PAPER CO., LTD (550022046)
    Establishment
    NameAddressID/FEIBusiness Operations
    DOBOLV (QUANZHOU) PAPER CO., LTD550022046manufacture(79891-002)
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