Z-bum

Z-bum
SPL v11
SPL
SPL Set ID 2a36f396-3a30-3f3f-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2023-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (22 g)
Inactive Ingredients
Cetyl Alcohol Caprylyl Glycol Light Mineral Oil Aloe Vera Leaf Glycerin Chlorphenesin Water Stearyl Alcohol Alpha-tocopherol Petrolatum Phenoxyethanol Polyoxyl 20 Cetostearyl Ether

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-12-01

Description

Z-Bum NDC 58809-375-04 4 oz. (113 grams)

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Z-Bum NDC 58809-375-04 4 oz. (113 grams)

Uses

■ helps treat and prevent diaper rash

■ protects chafed skin due to diaper rash and helps protect skin from wetness

Section 42229-5

Z-Bum

NDC 58809-375-04

4 oz. (113 grams)

Warnings

For external use only

Directions

■ change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.

■ apply cream liberally as often as necessary, with each diaper change, especially at

bedtime or anytime when exposure to wet diapers may be prolonged.

Active Ingredient

Zinc Oxide 22%

Other Information

■ store at 20-30°C (68-86°F)

Inactive Ingredients

aloe barbadensis leaf juice, caprylyl glycol, ceteareth- 20, cetyl alcohol, chlorphenesin, glycerine, mineral oil, petrolatum, phenoxyethanol, purified water, stearyl alcohol, tocopheryl acetate (vitamin E)

Questions Or Comments?

Call 1-888-535-0305

Distributed by: GM Pharmaceuticals, Inc. Arlington, TX 76018

Principal Display Panel

NDC 58809-375-04



Z-BUM

Zinc Oxide 22% (Skin Protectant)

Diaper Rash Cream

Premium Protection

Helps heal, soothe, and prevent diaper rash

Protects chafed skin

SOOTHING ALOE & VITAMIN E

Gentle on sensitive skin



NET WT 4 oz (113 grams)

When Using This Product

do not get into eyes.

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 Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

■ helps treat and prevent diaper rash

■ protects chafed skin due to diaper rash and helps protect skin from wetness

Section 42229-5 (42229-5)

Z-Bum

NDC 58809-375-04

4 oz. (113 grams)

Purpose

Skin Protectant

Warnings

For external use only

Directions

■ change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.

■ apply cream liberally as often as necessary, with each diaper change, especially at

bedtime or anytime when exposure to wet diapers may be prolonged.

Active Ingredient (Active ingredient)

Zinc Oxide 22%

Other Information (Other information)

■ store at 20-30°C (68-86°F)

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, caprylyl glycol, ceteareth- 20, cetyl alcohol, chlorphenesin, glycerine, mineral oil, petrolatum, phenoxyethanol, purified water, stearyl alcohol, tocopheryl acetate (vitamin E)

Questions Or Comments? (Questions or comments?)

Call 1-888-535-0305

Distributed by: GM Pharmaceuticals, Inc. Arlington, TX 76018

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 58809-375-04



Z-BUM

Zinc Oxide 22% (Skin Protectant)

Diaper Rash Cream

Premium Protection

Helps heal, soothe, and prevent diaper rash

Protects chafed skin

SOOTHING ALOE & VITAMIN E

Gentle on sensitive skin



NET WT 4 oz (113 grams)

When Using This Product (When using this product)

do not get into eyes.

Stop Use and Ask A Doctor If (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 Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)