FDA.reportPublic FDA data

DERMOGEN (Zinc Oxide Cream)

Manufacturer
KRAMER NOVIS
Effective date
2025-11-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:16:38

Label at a glance#

ProductDERMOGEN
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

• 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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15.25%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

 • helps treat and prevent diaper rash 

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

Warning

WARNINGS SECTION

​• 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Other information

STORAGE AND HANDLING SECTION

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

SPL UNCLASSIFIED SECTION

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.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DERMOGENDERMOGEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1793915zinc oxide 15.25 % Topical CreamPSN3
1793915zinc oxide 153 MG/ML Topical CreamSCD3
1793915zinc oxide 15.25 % Topical CreamSY3
1793915ZNO 153 MG/ML Topical CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52083-680-042025-11-18C16284748780-12cef2736-6d14-d83d-e063-dadaa90ab31fDERMOGEN (Zinc Oxide Cream)
52083-680-042025-01-30C16284748780-12cef2736-6d14-d83d-e063-dadaa90ab31fDERMOGEN (Zinc Oxide Cream)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-680-04DERMOGEN113.4 g in 1 JARCREAM113.43

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52083-68052083-680-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
VITAMIN A81G40H8B0TIACT
VITAMIN D9VU1KI44GPIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
PETROLATUM4T6H12BN9UIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DERMOGENZINC OXIDEKRAMER NOVIS38e02d1c-c143-4da6-ad32-a3ce2861aac52025-11-14WarningsExact identifier
ndc (package): 52083-680-04
ndc (product): 52083-680
ndc11 (package): 52083068004
spl id: 2a461bfd-7006-4b64-addf-474ee1fbd48f
spl set id: 38e02d1c-c143-4da6-ad32-a3ce2861aac5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.