Label: PERIFOAM- 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 2, 2013

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  • Uses

    PeriFoam™ is a safe, non-stinging foaming cleanser, which effectively kills odors and microorganisms on the skin, including the perineal area and around stoma sites and gastro-intestinal tube entry paints. PeriFoam™ will not bum or cause discomfort on irritated or tender skin, but will gently soften and moisturize as it cleans.

  • Warnings

    For external use only. Discontinue use ~ irritation and redness develop.

    If condition persists for more than 48 hours, consult a doctor.

    Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance.

  • Directions

    For Perineal Area and Around Stoma Site

    Spray PeriFoam™ on the perineal area or stoma site. Remove excess debris quickly. Spray PeriFoam™ again and gently wipe with water dampened cloth. Rinse with water:

    For Gastro-Intestinal Tube Sites

    Spray PeriFoam™ around the entry site. Gently clean with a damp cloth. Rinse with water. Repeat as necessary. After cleaning the area. Apply SkinSeal™skin protectant around the site as directed by label.

  • Ingredients

    Active Ingredient

    Benzethonium Chloride, 0.2

    Other Ingredients

    purified water, non-ionic surtactants, fragrance, polyaminopropyl biguanide, aloe vera, dexpanthenol, disodium EDTA, and vitamin E.

  • STORAGE AND HANDLING

    Store between 59"-86" F (15-30°C)

  • SPL UNCLASSIFIED SECTION

    Manufactured By:
    Sage Pharmaceuticals, Inc.
    Shreveport, LA 71109

  • PRINCIPAL DISPLAY PANEL - 237ml Bottle Label

    NDC 59243-110-08

    PeriFoam™
    ANTI-BACTERIAL FOAMING CLEANSER

    Active Ingredient: Benzethonium Chloride, 0.2%

    REDUCES ODOR AND CONTAINS NO DYES

    For foaming action, pull out tip of spray nozzle.

    SHAKE WELL BEFORE USING

    NET CONTENTS: 8 FL. OZ. (237ml)

    Principal Display Panel - 237ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    PERIFOAM 
    benzethonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59243-110
    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
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHERSOLAN (UNII: O03S90U1F2)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    CAPRIC DIETHANOLAMIDE (UNII: SHH19DQ1DH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59243-110-08237 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A11/21/2000
    Labeler - Sage Pharmaceuticals, Inc. (626120919)
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