Label: CLUB WIPES USA SANITIZING WIPES- benzalkonium chloride cloth

  • NDC Code(s): 80976-101-01, 80976-101-02, 80976-101-03, 80976-101-04, view more
    80976-101-05
  • Packager: Bubble Marketing Llc
  • 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 April 5, 2022

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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.12%

  • Purpose

    Antiseptic

  • Uses

    • 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 in the eyes.

    When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if irritation and redness develop. If 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.

    • Children under six years of age should be supervised 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

    Manufactured for: BUBBLE MARKETING

    P.O. Box 19121 • Topeka, KS 66619

    Tel: 785.862.0340 • Fax: 785.862.0347

    www.clubwipesusa.com

    Kills 99.99% of germs

    • Wet wipes cleans and sanitizes

    • 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: Cut small "V" out of the bag and pull Styrofoam® core out of the center of the roll. Pull the first towel from the center of the roll approximately 6 to 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 trash after use. Do not flush.

    CAUTION:May irritate eyes.

    See side panel for further precautions and first aid instructions.

    KEEP OUT OF REACH OF CHILDREN.

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    CLUB WIPES USA SANITIZING WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80976-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 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:80976-101-05160 in 1 BAG12/03/2020
    13.02 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:80976-101-04900 in 1 BAG12/03/2020
    23.02 mL in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:80976-101-03800 in 1 BAG12/03/2020
    33.02 mL in 1 PACKAGE; Type 0: Not a Combination Product
    4NDC:80976-101-021000 in 1 BAG12/03/2020
    43.02 mL in 1 PACKAGE; Type 0: Not a Combination Product
    5NDC:80976-101-011250 in 1 BAG12/03/2020
    53.02 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 finalpart333A12/03/2020
    Labeler - Bubble Marketing Llc (079629047)
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