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Name:Baza Cleanse And Protect
Manufacturer:Coloplast Manufacturing Us, Llc
Category:Over-the-counter (OTC) Marketed Drugs


Baza Cleanse & Protect® Skin ProtectantAll-In-OnePerineal Lotion

BAZA CLEANSE AND PROTECT - dimethicone lotion 
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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Baza Cleanse & Protect®
Skin Protectant
All-In-One
Perineal Lotion

For At-Risk Skin Irritation Due to Incontinence

Drug Facts

Active ingredient

Dimethicone, 2%

Purpose

Diaper Rash Skin Protectant

Uses Helps treat and prevent minor skin irritation due to diaper rash. Helps seal out wetness.

Warnings

When using this product

  • avoid contact with eyes
  • not to be applied over deep or puncture wounds or lacerations.

Consult a doctor

  • if condition worsens or does not improve within 7 days.

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 right away.

Directions

  • change wet and soiled diapers promptly
  • spray affected area and gently wipe with clean, soft cloth
  • apply as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

Inactive ingredients allantoin, cetearyl alcohol, citric acid, diazolidinyl urea, glycerin, glyceryl stearate, isopropyl palmitate, methylparaben, panthenol, propylene glycol, propylparaben, sodium lauroyl lactylate, soybean oil, tocopheryl acetate (vitamin E), water

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 #7712
©2008-9, Coloplast Corp. Made in the U.S.A.

J8-1115

PRINCIPAL DISPLAY PANEL - 8 FL. OZ. (237 mL)

NDC 11701-047-05

Baza Cleanse & Protect®

Skin Protectant

All-In-One Perineal Lotion

For At-Risk Skin Irritation Due to Incontinence

Coloplast

8 FL. OZ. (237 mL)

PRINCIPAL DISPLAY PANEL - 8 FL. OZ. (237 mL)

BAZA CLEANSE AND PROTECT  
dimethicone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11701-047
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 20 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE  
CETOSTEARYL ALCOHOL  
ISOPROPYL PALMITATE  
.ALPHA.-TOCOPHEROL ACETATE, D-  
SOYBEAN OIL  
CITRIC ACID  
PANTHENOL  
GLYCERIN  
METHYLPARABEN  
PROPYLPARABEN  
PROPYLENE GLYCOL  
DIAZOLIDINYL UREA  
ALLANTOIN  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11701-047-22 4 g in 1 PACKET None
2 NDC:11701-047-05 227 g in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part347 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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