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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M016	04/06/2020

Labeler - Coloplast Manufacturing US, LLC (110326675)

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