BAZA CLEAR- petrolatum ointment

Baza Clear by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

For Skin Irritation Due to Incontinence

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Petrolatum, 96%

Purpose

Skin Protectant

Uses Helps treat and prevent minor skin irritation due to diaper rash. Helps prevent and temporarily protects chafed, chapped or cracked skin. 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally as often as necessary.

For Diaper Rash: cleanse the diaper area and allow to dry

• apply liberally as often as necessary, with each diaper change especially at bedtime or any time when exposure to wet diapers may be prolonged.

Inactive ingredients benzethonium chloride, BHT, cod liver oil, fragrance, green 6, sodium caseinate (CONTAINS MILK)

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.coloplast.com
Product #1006 ©2008-7, Coloplast Corp.
Made in the U.S.A.

G8-303

PRINCIPAL DISPLAY PANEL

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

NDC: 11701-048-014

Baza®Clear

Skin Protectant

Moisture Barrier Ointment

For Skin Irritation Due to Incontinence

Coloplast

NET WT. 5 OZ. (142 g)

INGREDIENTS AND APPEARANCE

BAZA CLEAR 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11701-048
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	960 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COD LIVER OIL (UNII: BBL281NWFG)
SODIUM CASEINATE (UNII: 7473P66J9E)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11701-048-22	4 g in 1 PACKET; Type 0: Not a Combination Product	06/15/2009
2	NDC: 11701-048-24	50 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2009
3	NDC: 11701-048-14	142 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/15/2009

Labeler - Coloplast Manufacturing US, LLC (110326675)

Registrant - Coloplast Corp (847436391)

Establishment
Name	Address	ID/FEI	Business Operations
Coloplast Manufacturing US, LLC		110326675	MANUFACTURE(11701-048)