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

Purpose

Skin Protectant

Description

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


Medication Information

Warnings

For external use only

Uses

■ helps treat and prevent diaper rash

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

Purpose

Skin Protectant

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.

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)

Description

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

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)

Section 42229-5

Z-Bum

NDC 58809-375-04

4 oz. (113 grams)

Active Ingredient

Zinc Oxide 22%

Questions Or Comments?

Call 1-888-535-0305

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

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

Warnings

For external use only

Uses

■ helps treat and prevent diaper rash

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

Purpose

Skin Protectant

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.

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)

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)

Section 42229-5 (42229-5)

Z-Bum

NDC 58809-375-04

4 oz. (113 grams)

Active Ingredient (Active ingredient)

Zinc Oxide 22%

Questions Or Comments? (Questions or comments?)

Call 1-888-535-0305

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

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

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