Other
For Perineal Clean-Up
Drug Facts
For external use only.
Bedside-care Perineal Wash
FDA Label NDC 11701-059
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Coloplast Manufacturing Us, Llc for the product Bedside-care Perineal Wash (NDC 11701-059). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Benzethonium Chloride 0.1%
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
Uses Protects against the risk of bacterial contamination in minor cuts, scrapes and burns.
Warnings
Warnings
Otc - When Using
When using this product: do not use in the eyes, with deep or puncture wounds, serious burns or animal bites.
Otc - Stop Use
Stop using this product:
- if skin irritation and redness develop
- if condition persists for more than 72 hours, consult a physician.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
Directions Cleanse the affected area according to protocol.
Inactive Ingredient
Inactive ingredients water, sodium lauroamphoacetate, cocamidopropyl betaine, glycerin, polysorbate 20, citric acid, quaternium-52, quaternium-15, tetrasodium EDTA
Protocol: Shake well before use. Cleansing: Spray on the affected perineal area and remove with a moist washcloth. Aids in the removal of urine, feces and other foreign material. Ostomy/Incontinence Appliance: To help control odor, spray into appliance before and after use.
Manufactured by: Coloplast A/S
DK-3050 Humlebaek, Denmark
Distributed by: Coloplast Corp.
Minneapolis, MN 55411 U.S.A.
1-800-533-0464 www.us.coloplast.com
Product #1453 ©2009-2, Coloplast Corp.
Made in the U.S.A.
B9-1383
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL - NET WT. 8 fl. oz. (237mL)
NDC 11701-059-05
Bedside-Care® Perineal Wash
Perineal Skin Cleanser
No-Rinse
Incontinent Cleanser
For Perineal Clean-Up
Coloplast
NET WT. 8 fl. oz. (237mL)
Principal Display Panel (NET WT. 8 fl. oz. (237mL))
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