BEDSIDE-CARE PERINEAL WASH- benzethonium chloride liquid

Bedside-Care Perineal Wash by

Drug Labeling and Warnings

Bedside-Care Perineal Wash by is a Otc medication manufactured, distributed, or labeled by Coloplast Manufacturing US, LLC, Coloplast Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

For Perineal Clean-Up

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzethonium Chloride 0.1%

Purpose

Antiseptic

Uses Protects against the risk of bacterial contamination in minor cuts, scrapes and burns.

Warnings

When using this product: do not use in the eyes, with deep or puncture wounds, serious burns or animal bites.

Stop using this product:

• if skin irritation and redness develop
• if condition persists for more than 72 hours, consult a physician.

For external use only.

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions Cleanse the affected area according to protocol.

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

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)

INGREDIENTS AND APPEARANCE

BEDSIDE-CARE PERINEAL WASH  
benzethonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11701-059
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	1 mL  in 1 L

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
QUATERNIUM-15 (UNII: E40U03LEM0)
GLYCERIN (UNII: PDC6A3C0OX)
QUATERNIUM-52 (UNII: 588EQF3H1P)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11701-059-04	0.118 L in 1 BOTTLE, SPRAY
2	NDC: 11701-059-05	0.237 L in 1 BOTTLE, SPRAY
3	NDC: 11701-059-09	3.8 L in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/15/2009

Labeler - Coloplast Manufacturing US, LLC (110326675)

Registrant - Coloplast Corp (847436391)

Establishment
Name	Address	ID/FEI	Business Operations
Coloplast Manufacturing US, LLC		110326675	MANUFACTURE