The following Structured Product Label (SPL) was submitted to the FDA by Sage Pharmaceuticals, Inc. for the product Perifoam (NDC 59243-110). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, warnings, otc - ask doctor, otc - keep out of reach of children, for perineal area and around stoma site, for gastro-intestinal tube sites, active ingredient, other ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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.
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:
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.
Benzethonium Chloride, 0.2
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
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)
* Please review the disclaimer below.
