BEDSIDE-CARE PERINEAL WASH - benzethonium chloride liquid 
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® Perineal Wash
Perineal Skin Cleanser
No-Rinse
Incontinent Cleanser

For 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, 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 - 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)

PRINCIPAL DISPLAY PANEL - NET WT. 8 fl. oz. (237mL)
BEDSIDE-CARE PERINEAL WASH  
benzethonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-059
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1 mL  in 1 L
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11701-059-040.118 L in 1 BOTTLE, SPRAY
2NDC:11701-059-050.237 L in 1 BOTTLE, SPRAY
3NDC:11701-059-093.8 L 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: af2cb1f8-f41b-470b-868c-edd654a970af
Set id: a5ec24bc-30cf-46d2-9048-07957be07d27
Version: 3
Effective Time: 20110630
 
Coloplast Manufacturing US, LLC