Label: ANTIMICROBIAL- body cleanser liquid

  • NDC Code(s): 68599-0214-4, 68599-0214-8
  • Packager: McKesson
  • 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 October 18, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient
    Benzalkonium Chloride 0.13%

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Uses
    a no-rinse topical antiseptic for reducing and inhibiting bacterial growth.

  • WARNINGS

    Warnings
    For external use only.
    When using this product

    • do not get into eyes

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • STOP USE

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    If swallowed, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Spray soiled and/or odorous (body and/or perineal) areas
    • Gently wipe clean
    • Repeat as necessary until all soils are removed and skin is clean
    • Pat dry
    • No rinsing necessary
    • Apply a protectant cream or paste as necessary
  • OTHER SAFETY INFORMATION

    Store at 40-95ºF (4-35ºC)

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Purified Water, Butylene Glycol, Glycerin, Polysorbate 20, Aloe Barbadensis Leaf Juice,
    Sodium Hyaluronate, Carthamus Tinctorius (Safflower) Oleosomes, Phenoxyethanol, Caprylyl Glycol,
    Chlorphenesin, Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3),
    Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C),
    Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E), Fragrance, Tetrasodium EDTA,
    Lysine, Histidine, Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline,
    Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine,
    (may contain Sodium Hydroxide, Citric Acid)

  • QUESTIONS

    Questions?
    Call 1-800-777-4908

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-0214-4

    McKesson

    Thera

    ANTIMICROBIAL BODY CLEANSER

    A no-rinse topical cleanser for reducing and inhibiting bacterial growth.

    Single Patient Use

    NET CONTENTS 4 fl. oz (118 mL)

    MFR # 53-AC4

    53-AC4

  • PRINCIPAL DISPLAY PANEL



    NDC 68599-0214-8

    McKesson

    Thera

    ANTIMICROBIAL BODY CLEANSER

    A no-rinse topical cleanser for reducing and inhibiting bacterial growth.

    Single Patient Use

    NET CONTENTS 8 fl. oz (237 mL)

    MFR # 53-AC8

    53-AC8

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL 
    body cleanser liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-0214
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 ug  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    VALINE (UNII: HG18B9YRS7)  
    LEUCINE (UNII: GMW67QNF9C)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LYSINE (UNII: K3Z4F929H6)  
    METHIONINE (UNII: AE28F7PNPL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    ARGININE (UNII: 94ZLA3W45F)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)  
    THREONINE (UNII: 2ZD004190S)  
    GLYCINE (UNII: TE7660XO1C)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    HISTIDINE (UNII: 4QD397987E)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    ALANINE (UNII: OF5P57N2ZX)  
    TYROSINE (UNII: 42HK56048U)  
    SERINE (UNII: 452VLY9402)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CYSTEINE (UNII: K848JZ4886)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-0214-4118 mg in 1 BOTTLE; Type 0: Not a Combination Product08/12/2019
    2NDC:68599-0214-8237 mg in 1 BOTTLE; Type 0: Not a Combination Product08/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/12/2019
    Labeler - McKesson (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions007118524manufacture(68599-0214)
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