Label: SANI-MAXX ANTIBACTERIAL 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 August 14, 2020

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  • Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic/Hand & Skin Sanitizer

  • INDICATIONS & USAGE

    USES 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 ears, eyes or mouth.

    • Avoid contact with 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.
    • Children should be supervised when using this product.
    • If swallowed, get medical help or contact Poison Control Centre immediately.
  • DIRECTIONS FOR USE:

    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.

  • Questions?

    Call +1 212.268.2121 (Mon-Fri 9am to 5pm)

  • SPL UNCLASSIFIED SECTION

    • Kill 99.9% of Germs and Bacteria.
    • Easily Removes Dirt.
    • Alcohol & Bleach Free.

    Aloe Vera

    Vitamin E

    Anti-bacterial

    Spulance Nonwoven

    CAUTION: KEEP OUT OF THE REACH OF CHILDREN

    Please dispose of used wipes responsibly.

    Do not dispose used wipes down the toilet.

    No Alcohol . No Bleach

    DISTRIBUTED BY: TV DIRECT LLC, 385 FIFTH AVENUE, SUITE 809

    NEW YORK, NY10016, USA

    Wipe Dimensions: 5.9 in. X 7.87 in. (14.9cm x 19.9cm)

    2020 TV Direct LLC.

    MADE IN CHINA

  • Packaging

    IMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    SANI-MAXX ANTIBACTERIAL WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78915-852
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BETAINE (UNII: 3SCV180C9W)  
    CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78915-852-8080 in 1 BAG08/12/2020
    10.491 mL in 1 PATCH; Type 0: Not a Combination Product
    2NDC:78915-852-7070 in 1 CANISTER06/09/2020
    20.468 mL in 1 PATCH; Type 0: Not a Combination Product
    3NDC:78915-852-5050 in 1 BAG06/09/2020
    30.28 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/09/2020
    Labeler - Tv Direct Llc (078829674)
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