Label: TALON ANTISEPTIC WIPES- alcohol, 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

    Alcohol 70% (V/V)

    Benzalkonium Chloride 0.10% (W/V)

  • Purpose

    Antiseptic

  • Uses

    • for hand washing to decrease bacteria on the skin.

    • Recommended for repeat use.

  • Warnings

    For external use only. Flammable.

    Keep away from heat or flame.

    Do not use if you have been diagnosed by a physician as being allergic to any of the ingredients.

    When using this product Keep out of eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or redness develops, and if condition persists for more than 71 hours.

    Keep out of reach of children unless under adult supervision, If swallowed seek medical assistance.

  • Directions

    • 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.

    • Manufacturing/Expiry Date: See package for details

  • Inactive ingredients

    Aloe Vera Extract, Betaine, Citric acid, Dodecyl polyglucoside, Glycerol, Hexadecylpyridinium Chloride, Propanediol, Sodium citrate, Vitamin E, Water(Aqua).

  • SPL UNCLASSIFIED SECTION

    P P E CARE KIT 

    MADE BY Talon® INTERNATIONAL INC.

    DISTRIBUTED BY:

    Talon International, 21900 Burbank Blvd.,

    Suite 101 Woodland Hills, CA 91367 USA

    Made in China

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    TALON ANTISEPTIC WIPES 
    alcohol, benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79891-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BETAINE (UNII: 3SCV180C9W)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79891-003-1010 in 1 BAG10/30/2020
    14.5 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(79891-003)
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