FDA Label for Bedside-care Perineal Wash

View Indications, Usage & Precautions

OTHER
OTC - ACTIVE INGREDIENT
OTC - PURPOSE
INDICATIONS & USAGE
WARNINGS
OTC - WHEN USING
OTC - STOP USE
OTC - KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
INACTIVE INGREDIENT
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bedside-care Perineal Wash Product Label

The following document was submitted to the FDA by the labeler of this product Coloplast Manufacturing Us, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

For Perineal Clean-Up

Drug Facts

For external use only.

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

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