Baza

Baza
SPL v7
SPL
SPL Set ID ed63df26-3879-46df-8e09-10be569b25be
Route
TOPICAL
Published
Effective Date 2024-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (120 mg) Dimethicone (10 mg)
Inactive Ingredients
Cetyl Alcohol Glyceryl Monostearate Tricontanyl Povidone Petrolatum Lanolin Peg-8 Stearate Propylene Glycol Peg-40 Stearate Edetic Acid Cod Liver Oil .alpha.-tocopherol Acetate, D- Butylated Hydroxytoluene Quaternium-15 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-06-15

Description

For Skin Irritation Due to Incontinence Protects Easy to apply and remove Seals out wetness


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses Helps treat and prevent minor skin irritation due to

diaper rash. Helps seal out wetness.

Dosage and Administration

Directions

  • change wet and soiled diapers promptly
  • apply to 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.
Description

For Skin Irritation Due to Incontinence Protects Easy to apply and remove Seals out wetness

Section 42229-5

For Skin Irritation Due to Incontinence

  • Protects
  • Easy to apply and remove
  • Seals out wetness
Section 50565-1

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control

Center right away.

Section 50567-7

When using this product

  • avoid contact with eyes
  • not to be applied over deep or puncture wounds or lacerations.
Section 50569-3

Consult a doctor

  • if condition worsens or does not improve within 7 days.
Section 51727-6

Inactive ingredients

BHT, cetyl alcohol, cod liver oil, EDTA, fragrance, glyceryl stearate, lanolin oil, PEG-8 stearate, PEG-40 stearate, petrolatum, propylene glycol, quaternium-15, tocopheryl acetate, tricontanyl PVP, water

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.cobplast.com

Product #1880 ©2008-7, Coloplast Corp.

Made in the U.S.A.

G8-773

Section 51945-4

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

NDC 11701-046-14

Baza ® Protect

Skin Protectant

Moisture Barrier Cream

For Skin Irritation Due to Incontinence

Coloplast

NET WT. 5 OZ. (142 g)

Section 55105-1

Purpose

Diaper Rash

Skin Protectant

Section 55106-9

Active ingredients

Zinc Oxide, 12%

Dimethicone, 1 %


Structured Label Content

Indications and Usage (34067-9)

Uses Helps treat and prevent minor skin irritation due to

diaper rash. Helps seal out wetness.

Dosage and Administration (34068-7)

Directions

  • change wet and soiled diapers promptly
  • apply to 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.
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

For Skin Irritation Due to Incontinence

  • Protects
  • Easy to apply and remove
  • Seals out wetness
Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control

Center right away.

Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes
  • not to be applied over deep or puncture wounds or lacerations.
Section 50569-3 (50569-3)

Consult a doctor

  • if condition worsens or does not improve within 7 days.
Section 51727-6 (51727-6)

Inactive ingredients

BHT, cetyl alcohol, cod liver oil, EDTA, fragrance, glyceryl stearate, lanolin oil, PEG-8 stearate, PEG-40 stearate, petrolatum, propylene glycol, quaternium-15, tocopheryl acetate, tricontanyl PVP, water

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.cobplast.com

Product #1880 ©2008-7, Coloplast Corp.

Made in the U.S.A.

G8-773

Section 51945-4 (51945-4)

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

NDC 11701-046-14

Baza ® Protect

Skin Protectant

Moisture Barrier Cream

For Skin Irritation Due to Incontinence

Coloplast

NET WT. 5 OZ. (142 g)

Section 55105-1 (55105-1)

Purpose

Diaper Rash

Skin Protectant

Section 55106-9 (55106-9)

Active ingredients

Zinc Oxide, 12%

Dimethicone, 1 %


Advanced Ingredient Data


Raw Label Data

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