PERIFOAM- benzethonium chloride solution 
Sage Pharmaceuticals, Inc.

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.

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Perifoam™

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.

Store between 59"-86" F (15-30°C)

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
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)

Revised: 8/2013
Document Id: bfc2c082-1a15-491d-84bd-a8ca08f00c68
Set id: 11fc588b-e9bf-4c0b-9ca9-531c7c717684
Version: 1
Effective Time: 20130802
 
Sage Pharmaceuticals, Inc.