Label: ANTI-BACTERIAL WET WIPES- benzalkonium chloride cloth

  • Category: HUMAN OTC DRUG LABEL

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 January 14, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic/Hand & Skin Sanitizer

  • USE

    Sanitizing Hand Wipes to help decrease bacteria on the skin.
    Recommended for single use.

  • WARNINGS

    Do not freeze. For external use only, Store at room temperature.
    Do not use in ears, eyes or mouth.
    Avoid contact with the eyes. In case of contact, flush eyes with water.
    Stop use and ask a doctor if redness or irritation develop and persist
    for more than 72 hours,

  • KEEP OUT OF REACH OF CHILDREN

    ●Keep out of reach of children.
    ●Children should be supervised when using this product.
    If swallowed, get medical help or contact Poison Control Centre
    immediately.

  • Directions

    Wipe liberally over the hands & body, rub into skin until dry,
    Recommended for single use.

  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ANTI-BACTERIAL WET WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78028-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLY(LAURYLGLUCOSIDE)-7 (UNII: VB00RDE21R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BETAINE (UNII: 3SCV180C9W)  
    CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78028-004-0150 in 1 PAIL07/20/2020
    16.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    2NDC:78028-004-0270 in 1 PAIL07/20/2020
    26.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    3NDC:78028-004-0380 in 1 PAIL07/20/2020
    36.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    4NDC:78028-004-04100 in 1 PAIL07/20/2020
    46.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    5NDC:78028-004-0530 in 1 BAG07/20/2020
    56.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    6NDC:78028-004-0640 in 1 BAG07/20/2020
    66.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    7NDC:78028-004-0750 in 1 BAG07/20/2020
    76.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    8NDC:78028-004-0860 in 1 BAG07/20/2020
    86.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    9NDC:78028-004-0980 in 1 BAG07/20/2020
    96.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    10NDC:78028-004-10150 in 1 PAIL07/20/2020
    106.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/20/2020
    Labeler - Dalian Daxin Nonwoven Technology Co., Ltd. (415363991)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dalian Daxin Nonwoven Technology Co., Ltd. 415363991manufacture(78028-004)