BAZA PROTECT- zinc oxide and dimethicone cream 
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®Protect
Skin Protectant
Moisture Barrier Cream

For Skin Irritation Due to Incontinence

Drug Facts

Active ingredients

Zinc Oxide, 12%

Dimethicone, 1 %

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
  • apply to 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

BHT, cetyl alcohol, cod liver oil, EDTA, fragrance, glyceryl stearate, lanolin oil, PEG-8 stearate, PEG-40 stearate, petrolatum, propylene glycol, quaternium-15, tocopheryl acetate, tricontanyl PVP, water

See crimp for lot no. and expiration date

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.cobplast.com
Product #1880 ©2008-7, Coloplast Corp.
Made in the U.S.A.

G8-773

PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142g)

NDC 11701-046-14

Baza®Protect

Skin Protectant

Moisture Barrier Cream

For Skin Irritation Due to Incontinence

Coloplast

NET WT. 5 OZ. (142 g)

PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142g)
BAZA PROTECT 
zinc oxide and dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-046
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE120 mg  in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
PETROLATUM (UNII: 4T6H12BN9U)  
LANOLIN (UNII: 7EV65EAW6H)  
PEG-8 STEARATE (UNII: 2P9L47VI5E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
EDETIC ACID (UNII: 9G34HU7RV0)  
COD LIVER OIL (UNII: BBL281NWFG)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
QUATERNIUM-15 (UNII: E40U03LEM0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11701-046-224 g in 1 PACKET; Type 0: Not a Combination Product06/15/2009
2NDC:11701-046-2357 g in 1 TUBE; Type 0: Not a Combination Product06/15/2009
3NDC:11701-046-14142 g in 1 TUBE; Type 0: Not a Combination Product06/15/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/15/2009
Labeler - Coloplast Manufacturing US, LLC (110326675)
Registrant - Coloplast Corp (847436391)
Establishment
NameAddressID/FEIBusiness Operations
Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-046)

Revised: 2/2018
Document Id: c5bc45ad-edc2-462e-8838-bd6300baee56
Set id: ed63df26-3879-46df-8e09-10be569b25be
Version: 5
Effective Time: 20180215
 
Coloplast Manufacturing US, LLC