Label: ANTIBACTERIAL BATHING- benzalkonium chloride cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2023

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antiseptic

  • Uses

    • to decrease bacteria on skin
  • Warnings

    For external use only

    Do not heat sealed package in microwave

    Ask a doctor before you use if you have:

    • Deep puncture wounds
    • Animal bites
    • Serious burns

    Keep out of reach of children.

    • In case of accidental ingestion seek medical help or contact a Poison Control Center immediately.
    • Gloves diminish sensitivity to heat
    • Closely monitor heat level with infants, unresponsive or skin sensitive individuals

    Do not use

    • In the eye
    • Longer than 1 week unless directed by a physician
    • Over raw surfaces or blistered areas
  • Directions

    • Cloths can be used at room temperature or heated in a wipes warmer for extra comfort. Warming Instructions:
    • single warming session at temperatures not to exceed 52˚C (125˚F) and
    • for a maximum of 200 hours.
    • Discard wipes that have been exposed to warming temperatures exceeding 52˚C (125˚F) or
    • stored longer than 200 hours in the warmer. Bathing Instructions:
    • Remove one cloth at a time to clean each area in the following order: 1. Neck & facial area; 2. Front torso; 3. Right arm; 4. Left arm; 5. Right leg; 6. Left leg; 7. Back torso; 8. Buttocks & perineal area
    • Allow skin to dry
    • Dispose of cloth in waste receptacle
    • Do not flush cloths in toilet
  • Inactive Ingredients

    Aqua, Phenoxyethanol, Sodium Benzoate, Aloe Barbadensis Leaf Extract, Myristamidopropyl PG-Dimonium Chloride Phosphate, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Citric Acid, Disodium EDTA, Allantoin.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL BATHING 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63517-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MYRISTAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: E4821CQM1I)  
    LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63517-210-228 in 1 PACKET05/15/2019
    11 in 1 POUCH
    113.775 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00305/15/2019
    Labeler - Cardinal Health, Inc. (961027315)
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