BEDSIDE-CARE FOAM (ALCOHOL FREE)- benzethonium chloride shampoo

Bedside-Care Foam by

Drug Labeling and Warnings

Bedside-Care Foam 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 Full-Body Bathing And 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, scraps 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 7 days, 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 purified water, sodium lauroamphoacetate, cocamidopropyl betaine, glycerin, polysorbate 20, quaternium-52, citric acid, quaternium-15, fragrance, tetrasodium EDTA, green 5

Protocol: Rinsing is not required. Aids in the removal of urine, feces and other foreign material. Cleansing: apply to the affected perineal area and remove with a moist washcloth. Bathing: dispense 3-4 pumps in a basin with warm water and cleanse the skin. Shampooing: pump foam directly on dampened hair, lather and remove with a moist washcloth.

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 ©2007, Coloplast Corp.
Product #7145 Made in the U.S.A.

G7-1276

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC: 11701-052-04

Bedside-Care® Foam

Bathing & Perineal Skin Cleanser

No-Rinse Foaming
Body Wash, Shampoo
& Incontinent Cleanser

For Full Body
Bathing and Perineal
Clean-Up

Coloplast

4 fl. oz. (118 mL)

INGREDIENTS AND APPEARANCE

BEDSIDE-CARE FOAM   (ALCOHOL FREE)
benzethonium chloride shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11701-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	100 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
QUATERNIUM-15 (UNII: E40U03LEM0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
QUATERNIUM-52 (UNII: 588EQF3H1P)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11701-052-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/15/2009
2	NDC: 11701-052-05	237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/15/2009

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(11701-052)