Label: SURF SANI ALL-PURPOSE 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 December 24, 2020

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  • Drug Facts

  • Active ingredient[s]

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Use[s]

    • For Personal Hand Hygiene to help prevent the spread of bacteria.
    • Use when soap and water are not available after changing diapers, assisting ill persons, and before contact with a person under medical care or treatment.
    • Recommended for repeat use.
  • Warnings

    For external use only.


    Do not use
    • Do not use in the eyes.


    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.


    Stop use and ask a doctor if irritation or redness develops. In condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

  • Directions

    • Wet hands thoroughly with product and allow to dry.
    • Supervise children under 6 years of age when using this product.

  • Other information

    • Store in a cool dry place

  • Inactive ingredients

    Water, Aloe Barbadensis Leaf Juice, Polysorbate 20, Glycerin, Potassium Sorbate, Fragrance, Citric Acid, Disodium EDTA, Tocopheryl Acetate (Vitamin E)

  • SPL UNCLASSIFIED SECTION

    • Kills 99.99% of Germs!
    • Easily Removes Dirt
    • Alcohol & Bleach Free

    PERFECT FOR CLEANING WHILE AWAY FROM SOAP AND WATER!

    Shopping          School

    Automotive      Restaurants

    Office                Movie Theaters

    Transport         Gym

    Air Travel         Sporting Events  

    Manufactured for EST, Inc.
    15785 S. Keeler Terrace, Olathe, KS 66062
    Tel: 913-764-4900 Fax: 913-764-4901
    www.estchemcials.com

    • Kills 99.99% of Germs
    • Wet wipes cleaners and sanitizers
    • Designed to use in health facilities, health clubs, schools and wherever germs are present.
    • Board Certified Dermatologist Tested & Approved as a non-sensitizer nor irritant to skin.

    DIRECTIONS FOR DISPENSING: Pull the first towel from the center of the roll approximately 6–8 inches. Place bag in the dispenser and at the
    same time feed the first towel through the opening on the dispenser.


    DISPOSAL: Offer empty container for recycling. If recycling is not available, discard container in trash. Discard towel in the trash after use.
    Do not flush wipe.

    CAUTION: May irritate eyes.
    See side panel for further precaution and first aid instructions.


    KEEP OUT OF REACH OF CHILDREN

  • Packaging

    IMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    SURF SANI ALL-PURPOSE WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77845-100
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77845-100-014 in 1 CARTON12/28/2020
    11000 in 1 BAG
    13.15 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:77845-100-0212 in 1 CARTON12/28/2020
    2160 in 1 PACKET
    23.15 mL in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:77845-100-034 in 1 CARTON12/28/2020
    31500 in 1 BAG
    33.15 mL in 1 PACKAGE; Type 0: Not a Combination Product
    4NDC:77845-100-044 in 1 CARTON12/28/2020
    4800 in 1 BAG
    43.15 mL in 1 PACKAGE; Type 0: Not a Combination Product
    5NDC:77845-100-0512 in 1 CARTON12/28/2020
    5100 in 1 PACKET
    53.15 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 finalpart333A12/28/2020
    Labeler - Enviro Science Technology Inc (604179080)
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