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


Bedside-Care® No-Rinse CleanserNo-Rinse Body Wash,Shampoo &-Incontinent Cleanser

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 Type HUMAN OTC DRUG Item Code (Source) NDC:11701-020
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZETHONIUM CHLORIDE (BENZETHONIUM) BENZETHONIUM CHLORIDE 1 mL  in 1000 mL
Inactive Ingredients
Ingredient Name Strength
D&C GREEN NO. 5  
CITRIC ACID  
EDETATE SODIUM  
QUATERNIUM-15  
POLYSORBATE 20  
COCAMIDOPROPYL BETAINE  
GLYCERIN  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11701-020-04 118 mL in 1 BOTTLE, SPRAY None
2 NDC:11701-020-05 237 mL in 1 BOTTLE, SPRAY None
3 NDC:11701-020-09 3800 mL 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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