dermogen (zinc oxide cream)

dermogen (zinc oxide cream)
SPL v3
SPL
SPL Set ID 38e02d1c-c143-4da6-ad32-a3ce2861aac5
Route
topical
Published
Effective Date 2025-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (15.25 g)
Inactive Ingredients
butylated hydroxytoluene diazolidinyl urea methylparaben mineral oil propylene glycol propylparaben vitamin a vitamin d .alpha.-tocopherol petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-04-04

Purpose

Skin protectant

Description

Zinc Oxide 15.25%


Medication Information

Uses

 • helps treat and prevent diaper rash 

 • protects chafed skin due to diaper rash and helps seal out wetness

Purpose

Skin protectant

Directions

• change wet or soiled diapers promptly. • cleanse the diaper area • allow to dry • apply cream liberally as often as necessary, with each diaper, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

• Store at controlled room temperature 15°-30°C (59°-86°F) • Do not use if seal is broken

Inactive Ingredients

Butylhydroxytoluene, diazolidinyl urea, fragrance, methylparaben, mineral oil, propylene glycol, propylparaben, Vitamin A, Vitamin D, Vitamin E and white petrolatum.

Description

Zinc Oxide 15.25%

Section 42229-5

For the Treatment & Prevention of Diaper Rash

Contains the same active ingredient as Dermocrem®

Manufactured in the USA for Kramer Novis,

San Juan, PR 00917. T: (787) 767-2072.

www.kramernovis.com

Dermocrem® is a registered trademark of Forest Tosara Ltd. This product is not manufactured, distributed or marketed by Forest Tosara Ltd.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warning

​• For external use only.

When using this product • do not get into eyes

Stop and ask a doctor if • condition worsens • symptoms lasts more than 7 days or clear up and occur again within a few days

Packaging

Drug Facts

Active Ingredient

Zinc Oxide 15.25%


Structured Label Content

Uses

 • helps treat and prevent diaper rash 

 • protects chafed skin due to diaper rash and helps seal out wetness

Purpose

Skin protectant

Directions

• change wet or soiled diapers promptly. • cleanse the diaper area • allow to dry • apply cream liberally as often as necessary, with each diaper, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information (Other information)

• Store at controlled room temperature 15°-30°C (59°-86°F) • Do not use if seal is broken

Inactive Ingredients (Inactive ingredients)

Butylhydroxytoluene, diazolidinyl urea, fragrance, methylparaben, mineral oil, propylene glycol, propylparaben, Vitamin A, Vitamin D, Vitamin E and white petrolatum.

Section 42229-5 (42229-5)

For the Treatment & Prevention of Diaper Rash

Contains the same active ingredient as Dermocrem®

Manufactured in the USA for Kramer Novis,

San Juan, PR 00917. T: (787) 767-2072.

www.kramernovis.com

Dermocrem® is a registered trademark of Forest Tosara Ltd. This product is not manufactured, distributed or marketed by Forest Tosara Ltd.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warning

​• For external use only.

When using this product • do not get into eyes

Stop and ask a doctor if • condition worsens • symptoms lasts more than 7 days or clear up and occur again within a few days

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Zinc Oxide 15.25%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)