Monday, October 3, 2016

Bedside Care




Generic Name: benzethonium chloride

Dosage Form: topical liquid
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 - 8 FL. OZ (237 mL)


NDC 11701-053-05


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


8 FL. OZ (237 mL)










BEDSIDE-CARE  
benzethonium chloride  liquid










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)11701-053
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (BENZETHONIUM)BENZETHONIUM CHLORIDE1 mL  in 1000 mL






















Inactive Ingredients
Ingredient NameStrength
CITRIC ACID 
EDETATE SODIUM 
QUATERNIUM-15 
GLYCERIN 
QUATERNIUM-52 
POLYSORBATE 20 
COCAMIDOPROPYL BETAINE 
SODIUM LAUROAMPHOACETATE 
WATER 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
111701-053-04118 mL In 1 BOTTLE, SPRAYNone
211701-053-05237 mL In 1 BOTTLE, SPRAYNone










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
Revised: 06/2011Coloplast Manufacturing US, LLC




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