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Name:Bedside-care Perineal Wash
Manufacturer:Coloplast Manufacturing Us, Llc
Category:Over-the-counter (OTC) Marketed Drugs


Bedside-Care® Perineal WashPerineal Skin CleanserNo-RinseIncontinent Cleanser

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 Type HUMAN OTC DRUG Item Code (Source) NDC:11701-059
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZETHONIUM CHLORIDE (BENZETHONIUM) BENZETHONIUM CHLORIDE 1 mL  in 1 L
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID  
EDETATE SODIUM  
QUATERNIUM-15  
GLYCERIN  
POLYSORBATE 20  
COCAMIDOPROPYL BETAINE  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11701-059-04 0.118 L in 1 BOTTLE, SPRAY None
2 NDC:11701-059-05 0.237 L in 1 BOTTLE, SPRAY None
3 NDC:11701-059-09 3.8 L in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 06/15/2009

Labeler - Coloplast Manufacturing US, LLC (110326675)
Registrant - Coloplast Corp (847436391)
Establishment
Name Address ID/FEI Operations
Coloplast Manufacturing US, LLC 110326675 MANUFACTURE

Revised: 06/2010 Coloplast Manufacturing US, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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