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

Drug Facts

Active ingredients

Zinc Oxide, 12%
Dimethicone, 1%

Purpose

Skin Protectant

Uses

Warnings

For external use only.

When using this product

  • Do not get into eyes.
  • Do not use on:
    • deep or puncture wounds
    • animal bites
    • serious burns.

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Water, petrolatum, lanolin oil, propylene glycol, PEG- 40 stearate, cetyl alcohol, PEG-8 stearate, glyceryl stearate, triacontanyl PVP, fragrance, caprylyl glycol, caprylhydroxamic acid, ethylhexylglycerin, propanediol, tocopheryl acetate, EDTA

Manufactured by: Coloplast A/S DK-3050 Humlebaek, Denmark

Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A.

PRINCIPAL DISPLAY PANEL - 142 g Tube Label

NDC 11701-082-24

Baza® Protect

Skin Protectant

Moisture
Barrier Cream

For Skin Irritation
Due to Incontinence

Coloplast

NET WT. 5 OZ. (142 g)

PRINCIPAL DISPLAY PANEL - 142 g Tube Label
BAZA PROTECT 
zinc oxide and dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-082
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
Water (UNII: 059QF0KO0R)  
Petrolatum (UNII: 4T6H12BN9U)  
Lanolin Oil (UNII: OVV5IIJ58F)  
Propylene glycol (UNII: 6DC9Q167V3)  
PEG-40 stearate (UNII: ECU18C66Q7)  
cetyl alcohol (UNII: 936JST6JCN)  
PEG-8 stearate (UNII: 2P9L47VI5E)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Tricontanyl Povidone (UNII: N0SS3Q238D)  
Caprylyl glycol (UNII: 00YIU5438U)  
Caprylhydroxamic acid (UNII: UPY805K99W)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Propanediol (UNII: 5965N8W85T)  
.alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8)  
EDETIC ACID (UNII: 9G34HU7RV0)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11701-082-24142 g in 1 TUBE; Type 0: Not a Combination Product04/06/2020
2NDC:11701-082-0357 g in 1 TUBE; Type 0: Not a Combination Product04/06/2020
3NDC:11701-082-224 g in 1 PACKET; Type 0: Not a Combination Product04/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34704/06/2020
Labeler - Coloplast Manufacturing US, LLC (110326675)
Establishment
NameAddressID/FEIBusiness Operations
Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-082)

Revised: 4/2020
Document Id: 7c0737eb-3650-4e93-bd06-56e886e6cd61
Set id: 256dfcfc-a91c-49b0-9439-452586a0880e
Version: 1
Effective Time: 20200403
 
Coloplast Manufacturing US, LLC