BAZA CLEANSE AND PROTECT- dimethicone cloth
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 Cleanse & Protect® Cloth

Drug Facts

Active Ingredients(s)

Dimethicone, 3%

Purpose(s)

Skin Protectant

Uses

Temporarily protects the skin and helps relieve 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.

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 immediately.

Consult a doctor: if condition worsens or does not improve within 7 days.

Directions

Remove the stool with underpad or wipe.

Thoroughly cleanse the perineal area using Dimethicone wipe.
Dispose of soiled wipe in waste receptacle.
Change wet and soiled diapers promptly: wipe affected area as often as necessary, with each diaper change, especially when exposure to wet diapers may be prolonged.

Caution

Gloves diminish sensitivity to heat.

Do not use excessively hot wipe.

Closely monitor heat level with infants, unresponsive, and skin sensitive individuals.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Butylparaben, Citric Acid, Diazolidinyl Urea, Disodium Cocoamphodiacetate, Ethylparaben, Glycerin, Isobutylparaben, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Propylparaben, Tocopheryl Acetate, Water

Cloth material

Polyester rayon

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

PRINCIPAL DISPLAY PANEL - 24 g Packet Label

Product Sample Not for Sale

NDC 11701-628-08

Baza Cleanse & Protect® Cloth
Baza Cleanse & Protect® Cloth with Dimethicone

Skin Protectant

All-In-One
Perineal Cloth
with Dimethicone

Helps To
Prevent
Incontinence
Associated
Dermatitis

Coloplast

Contents: 8 Disposable Cloths

Principal Display Panel - 24 g Packet Label

BAZA CLEANSE AND PROTECT
dimethicone cloth

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:11701-628
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (DIMETHICONE)	DIMETHICONE	3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF
BUTYLPARABEN
CITRIC ACID MONOHYDRATE
DIAZOLIDINYL UREA
DISODIUM COCOAMPHODIACETATE
ETHYLPARABEN
GLYCERIN
ISOBUTYLPARABEN
METHYLPARABEN
PHENOXYETHANOL
POLYSORBATE 20
PROPYLENE GLYCOL
PROPYLPARABEN
WATER

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11701-628-08	24 g in 1 PACKET

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	12/04/2013

Labeler - Coloplast Manufacturing US, LLC (110326675)

Registrant - Coloplast Corp (847436391)

Name	Address	ID/FEI	Business Operations
Establishment
Coloplast Manufacturing US, LLC		110326675	MANUFACTURE(11701-628)

Revised: 12/2013

Document Id: 06fbe1c1-c962-40c8-812d-498ec11daf3e

Set id: 010235b4-228e-499e-abf4-29d0ca8696f8

Version: 1

Effective Time: 20131223

Coloplast Manufacturing US, LLC