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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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 TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-047
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE 
CETOSTEARYL ALCOHOL 
ISOPROPYL PALMITATE 
.ALPHA.-TOCOPHEROL ACETATE, D- 
SOYBEAN OIL 
CITRIC ACID 
PANTHENOL 
GLYCERIN 
METHYLPARABEN 
PROPYLPARABEN 
SODIUM LAUROYL LACTYLATE 
PROPYLENE GLYCOL 
DIAZOLIDINYL UREA 
ALLANTOIN 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:11701-047-224 g in 1 PACKETNone
2NDC:11701-047-05227 g in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34706/15/2009

Labeler - Coloplast Manufacturing US, LLC (110326675)
Registrant - Coloplast Corp (847436391)
Establishment
NameAddressID/FEIOperations
Coloplast Manufacturing US, LLC110326675MANUFACTURE

Revised: 06/2011 Coloplast Manufacturing US, LLC