FDA.reportPublic FDA data

DermaMed

Manufacturer
DermaRite Industries, LLC
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:40:53

Label at a glance#

ProductDermaMed
Active ingredientALUMINUM HYDROXIDE
Label structure11 sections

Indications and uses

Dries the oozing and weeping of poison: ivy, oak, or sumac, or other skin irritations.

Dosage and administration

Apply liberally to the affected area as needed or as directed by a physician.

Label contents#

Full prescribing information#

​Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Aluminum Hydroxide Gel 2%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

Dries the oozing and weeping of poison: ivy, oak, or sumac, or other skin irritations.

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes. In case of contact, flush thoroughly with water.

Warnings

OTC - ASK DOCTOR SECTION

Stop and ask a doctor if

  • condition worsens
  • ​symptoms last more than 7 days or clear up and occur again within a few days

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

​In case of accidental ingestion contact a Physician or Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally to the affected area as needed or as directed by a physician.

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature (59º- 86ºF)
  • You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Petrolatum, Lanolin, Water, Propylene Glycol, Stearyl Alcohol, Calcium Carbonate, Magnesium Hydroxide, Zinc Chloride, DMDM Hydantoin, Methylparaben, Propylparaben, Sodium Laureth Sulfate, Lanolin Alcohol, Cholecalciferol, Zea Mays (Corn) Oil, Retinyl Palmitate, Citric Acid, Sodium Chloride

Questions?

OTC - QUESTIONS SECTION

Call 800-337-6296 Mon - Fri 9AM - 5PM EST.

DermaMed Package Label and Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage LabelCase LabelCase Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61924-214-042024-12-06C16284748780-1d6a99b39-8624-a426-e053-dadaa90af4c2DermaMed
61924-214-042022-01-28C16284748780-1d6a99b39-8624-a426-e053-dadaa90af4c2DermaMed

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61924-214-04DermaMed106 g in 1 TUBEOINTMENT1063

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61924-214DERMAMED (SKIN PROTECTANT) OINTMENT [DERMARITE INDUSTRIES, LLC]3Legacy NDC, 1 package rows20241208_5bd4173d-8794-3d28-e053-2991aa0a06a9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61924-214-04GM - Gram61924-2147a829a84-3808-4cd3-a658-67c090c6769a12017-11-06

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61924-21461924-214-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHOLECALCIFEROL1C6V77QF41IACT
LANOLIN7EV65EAW6HIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
MAGNESIUM HYDROXIDENBZ3QY004SIACT
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE)9Q5W5G6461IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
DMDM HYDANTOINBYR0546TOWIACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CORN OIL8470G57WFMIACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM CHLORIDE451W47IQ8XIACT
ZINC CHLORIDE86Q357L16BIACT
PROPYLPARABENZ8IX2SC1OHIACT
STEARYL ALCOHOL2KR89I4H1YIACT
PETROLATUM4T6H12BN9UIACT
CALCIUM CARBONATEH0G9379FGKIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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
288a148c-2bcb-5054-e063-6394a90a97555bd4173d-8794-3d28-e053-2991aa0a06a92024-12-05WarningsExact identifier
spl id: 288a148c-2bcb-5054-e063-6394a90a9755
spl set id: 5bd4173d-8794-3d28-e053-2991aa0a06a9

Reported adverse events (FAERS/openFDA)#

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