BAZA PROTECT- zinc oxide and dimethicone cream

Baza Protect by

Drug Labeling and Warnings

Baza Protect by is a Otc medication manufactured, distributed, or labeled by Coloplast Manufacturing US, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Zinc Oxide, 12%
Dimethicone, 1%

Purpose

Skin Protectant

Uses

• Helps prevent and temporarily protects chafed, chapped or cracked skin.
• Helps seal out wetness.

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

• Apply to affected area and gently wipe with clean, soft cloth.
• Apply as needed, especially at bedtime or any time when exposure to moisture may be prolonged.

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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

BAZA PROTECT 
zinc oxide and dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11701-082
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	120 mg  in 1 g
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11701-082-24	142 g in 1 TUBE; Type 0: Not a Combination Product	04/06/2020
2	NDC: 11701-082-03	57 g in 1 TUBE; Type 0: Not a Combination Product	04/06/2020
3	NDC: 11701-082-22	4 g in 1 PACKET; Type 0: Not a Combination Product	04/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	04/06/2020

Labeler - Coloplast Manufacturing US, LLC (110326675)

Establishment
Name	Address	ID/FEI	Business Operations
Coloplast Manufacturing US, LLC		110326675	MANUFACTURE(11701-082)