BAZA CLEANSE AND PROTECT- dimethicone lotion

Baza Cleanse and Protect by

Drug Labeling and Warnings

Baza Cleanse and Protect 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 At-Risk Skin Irritation Due to Incontinence

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Dimethicone, 2%

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
• spray 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 allantoin, cetearyl alcohol, citric acid, diazolidinyl urea, glycerin, glyceryl stearate, isopropyl palmitate, methylparaben, panthenol, propylene glycol, propylparaben, sodium lauroyl lactylate, soybean oil, tocopheryl acetate (vitamin E), water

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 #7712
©2008-9, Coloplast Corp. Made in the U.S.A.

J8-1115

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 8 FL. OZ. (237 mL)

NDC: 11701-047-05

Baza Cleanse & Protect®

Skin Protectant

All-In-One Perineal Lotion

For At-Risk Skin Irritation Due to Incontinence

Coloplast

8 FL. OZ. (237 mL)

INGREDIENTS AND APPEARANCE

BAZA CLEANSE AND PROTECT 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11701-047
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
SOYBEAN OIL (UNII: 241ATL177A)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PANTHENOL (UNII: WV9CM0O67Z)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11701-047-22	4 g in 1 PACKET; Type 0: Not a Combination Product	06/15/2009
2	NDC: 11701-047-05	227 g in 1 BOTTLE; 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(11701-047)