Label: SEPTICARE- benzethonium chloride solution

  • 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 August 5, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzethonium Chloride 0.2%

  • Purpose

    Antiseptic

  • Uses

    For skin irritation due to incontinence. Protects against the risk of bacterial contamination in minor cuts, scrapes, and burns.

  • Warnings

    When using this product

    Do not use in the eyes, with deep or puncture wounds, serious burns or animal bites.

    Stop using this product

    If skin irritation and redness develop.

    • If condition persists for more than 72 hours, consult a physician.

    For external use only.

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

  • Directions

    Adjust nozzle to spray or stream setting. Spray/stream Septicare directly into wound, or soak gauze pad and pack the wound. Cover with secondary dressing of choice. Change dressing as needed, no rinsing necessary.

  • Inactive Ingredients

    water, sodium chloride 0.9%, nonionic surfactant, biguanide.

  • STORAGE AND HANDLING

    Store at controlled room temperature between 50°F (10°C) and 86°F (30°C).

  • SPL UNCLASSIFIED SECTION

    Protocol: Shake before use. Cleaning: Spray on the affected peritoneal area and remove with a moist washcloth. Aides in the removal of urine feces and other foreign material.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    SAGE
    PHARMACEUTICALS
    5408 Interstate Drive
    Shreveport, LA 71109

  • PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

    NDC 59243-100-08

    SeptiCare™

    Wound Cleanser and Deodorant

    Antiseptic

    Saline based • No-rinse • Non-toxic • Non-stinging

    Net Contents: 8 fl.oz. (240 mL)

    PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SEPTICARE 
    benzethonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59243-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59243-100-08240 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A06/26/1999
    Labeler - Sage Pharmaceuticals, Inc. (626120919)
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