Label: PRE-MOISTENED BATHING CLOTHS- 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 November 6, 2019

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.10%

  • Purpose

    Antibacterial

    (helps reduce germs)

  • Uses

    Helps kill germs that can potentially cause infection. 

    Helps eliminate odor. 

    Reduces cross contamination.

  • Warnings

    For external use only.

    Avoid contact with eyes.

    Do not use on deep or punctured wounds, serious burns or animal bites. If irritation or redness develops, and persists for more than 72 hours after use, stop use and seek medical help.

    Keep out of reach of children.

    If swallowed, get medical help or contact poison control center immediately.
    AAPCC: (800) 222-1222

  • DIRECTIONS FOR USE

    Remove one cloth at a time, cleanse the body as diagrammed below. No rinsing or drying is necessary. Use one pre-moistened
    cloth for each of the following areas:

    image description

    DO NOT FLUSH! Dispose bathing cloths in trash

  • Other Information

    Protect from freezing. Pre-moistened bathing cloths made from spunlace fabric.

  • Inactive Ingredients

    Water, Propylene Glycol, Glycerine, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid, Cocamidopropylbetaine, Peg-12 Dimethicone, Disodium
    Cocoamphodiacetate, Polysorbate-20, Cyclopentasiloxane 5, Sodium Gluconate, Peg-40 Hydrogenated Castor Oil, Fragrance, Alpha Tocopheryl Acetate (Alpha Tocopheryl/Vitamin E), Citric Acid.

  • SPL UNCLASSIFIED SECTION

    A soft, convenient, and easy to use bathing alternative

    ALCOHOL FREE • pH BALANCED
    ANTI BACTERIAL • MICROWAVEABLE
    LATEX FREE • HYPOALLERGENIC
    VITAMIN E ENRICHED

    CHG COMPATIBLE

    Healthcare Facilities - Home Care Hikers - Cyclists - Campers - Truckers

    MICROWAVEABLE
    Pull Back the resealable tab approximately 1 inch and heat for 30 seconds.
    DO NOT OVERHEAT. DO NOT REHEAT.

    TEST TEMPERATURE TO AVOID BURNING SKIN.
    Check temperature prior to use, especially for infants or skin sensitive individuals.
    Remove gloves; heat sensitivity is reduced when wearing gloves.

    PRECAUTIONS
    Avoid direct contact with eyes. To prevent drying, do not store under sunlight or in high temperatures.
    Re-seal front label after each use.

    SPECIALLY MANUFACTURED
    FOR LEADING AGE SUPPLIES
    24700 Chagrin Blvd., Suite 104
    Cleveland, Ohio 44122
    www.bathinbag.com

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    PRE-MOISTENED BATHING CLOTHS 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69088-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.143 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69088-102-088 in 1 BAG; Type 0: Not a Combination Product11/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/01/2019
    Labeler - Leading Age Supplies (079338636)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ginni Filaments Limited650793412manufacture(69088-102)
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