BEDSIDE-CARE FOAM  (ALCOHOL FREE) - benzethonium chloride shampoo 
Coloplast Manufacturing US, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Bedside-Care® Foam
Bathing & Perineal Skin Cleanser
No-Rinse Foaming
Body Wash, Shampoo
& Incontinent Cleanser

For Full-Body Bathing And Perineal Clean-Up

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 - 8 FL. OZ (237 mL)

NDC 11701-052-05

Bedside-Care® Foam

Bathing & Perineal Skin Cleanser

No-Rinse Foaming Body Wash, Shampoo & Incontinent Cleanser

For Full-Body Bathing And Perineal Clean-Up

Coloplast

8 FL. OZ (237 mL)

PRINCIPAL DISPLAY PANEL - 8 FL. OZ (237 mL)
BEDSIDE-CARE FOAM   (ALCOHOL FREE)
benzethonium chloride shampoo
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11701-052
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (BENZETHONIUM) BENZETHONIUM CHLORIDE1 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
D&C GREEN NO. 5 
CITRIC ACID 
EDETATE SODIUM 
QUATERNIUM-15 
POLYSORBATE 20 
COCAMIDOPROPYL BETAINE 
QUATERNIUM-52 
GLYCERIN 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11701-052-04118 mL in 1 BOTTLE, SPRAY
2NDC:11701-052-05237 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/15/2009
Labeler - Coloplast Manufacturing US, LLC (110326675)
Registrant - Coloplast Corp (847436391)
Establishment
NameAddressID/FEIBusiness Operations
Coloplast Manufacturing US, LLC110326675MANUFACTURE

Revised: 6/2011
Document Id: c69b6faa-24c4-4094-870e-7bb1aea63f54
Set id: 3e8a37f0-3b44-4bba-8987-2717b54419f1
Version: 3
Effective Time: 20110630
 
Coloplast Manufacturing US, LLC