BEDSIDE-CARE - 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®
No-Rinse Cleanser
No-Rinse 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, 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, 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. Bathing: dispense 3-4 sprays in a basin with warm water and cleanse the skin. Shampooing: spray directly on dampened hair, lather and remove with a mois washcloth. Cleansing: apply to the affected perineal area 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
Product #1762 ©2009-2, Coloplast Corp.
Made in the U.S.A.

B9-612

PRINCIPAL DISPLAY PANEL - 8 fl. oz. (237 mL)

NDC 11701-020-05

Bedside-Care®

No-Rinse Cleanser

No-Rinse 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  
benzethonium chloride shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
CITRIC ACID (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11701-020-04118 mL in 1 BOTTLE, SPRAY
2NDC:11701-020-05237 mL in 1 BOTTLE, SPRAY
3NDC:11701-020-093800 mL in 1 BOTTLE
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: 0c76d9f5-4a95-47ec-92b3-9bff0100478c
Set id: 0c662992-3c83-482a-9634-4672eb9d1eab
Version: 3
Effective Time: 20110630
 
Coloplast Manufacturing US, LLC