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Bedside-Care by Coloplast Manufacturing US, LLC

Medically reviewed on February 15, 2018

Dosage form: shampoo
Ingredients: BENZETHONIUM CHLORIDE 100mg in 100mL
Labeler: Coloplast Manufacturing US, LLC
NDC Code: 11701-053

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.

Bedside-Care® Unscented 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:

  • 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 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, tetrasodium EDTA.

Protocol: Rinsing is not required. Aids in the removal of urine, feces and other foreign material. Cleansing: apply to the affected 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 #7146 Made in the U.S.A.

G7-1277

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 11701-053-04

Bedside-Care®Unscented 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)

BEDSIDE-CARE  
benzethonium chloride shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-053
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (BENZETHONIUM) BENZETHONIUM CHLORIDE100 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
EDETATE SODIUM 
QUATERNIUM-15 
GLYCERIN 
QUATERNIUM-52 
POLYSORBATE 20 
COCAMIDOPROPYL BETAINE 
SODIUM LAUROAMPHOACETATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:11701-053-04118 mL in 1 BOTTLE, SPRAY
2NDC:11701-053-05237 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/FEIOperations
Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-053)

 
Coloplast Manufacturing US, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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