FDA.reportPublic FDA data

Dermaphor

Manufacturer
DermaRite Industries, LLC
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:40:53

Label at a glance#

ProductDermaphor
Active ingredientPETROLATUM
Label structure13 sections

Indications and uses

Temporarily protects minor cuts, scrapes, burns. Temporarily protects and helps relieve chapped or cracked skin and lips. Helps protect skin from the drying effects of wind and cold weather.

Dosage and administration

Apply liberally to affected area as needed.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 44.28%

Purpose:

OTC - PURPOSE SECTION

Skin Protectant

Uses:

DOSAGE & ADMINISTRATION SECTION

  • Temporarily protects minor cuts, scrapes, burns.
  • Temporarily protects and helps relieve chapped or cracked skin and lips.
  • Helps protect skin from the drying effects of wind and cold weather.

Warnings:

WARNINGS SECTION

​For external use only.

Warnings:

OTC - WHEN USING SECTION

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 - DO NOT USE SECTION

Do not use ​on deep or puncture wounds, animal bites, or serious wounds.

​Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions:

INDICATIONS & USAGE SECTION

Apply liberally to affected area as needed.

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

Mineral Oil, Paraffin, Lanolin Alcohol

Questions?:

OTC - QUESTIONS SECTION

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

DermaPhor Package Label and Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Case labelCase labelPackage labelPackage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1088725DermaPhor 44 % Topical OintmentPSN4
1373226petrolatum 44 % Topical OintmentPSN4
1088725petrolatum 0.44 MG/MG Topical Ointment [DermaPhor]SBD4
1373226petrolatum 0.44 MG/MG Topical OintmentSCD4
1088725DermaPhor 0.44 MG/MG Topical OintmentSY4
1088725DermaPhor 44 % Topical OintmentSY4
1373226petrolatum 44 % Topical OintmentSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61924-184-042024-12-06C16284748780-1d6a99b39-374c-a426-e053-dadaa90af4c2DERMAPHOR
61924-184-082024-12-06C16284748780-1d6a99b39-374c-a426-e053-dadaa90af4c2DERMAPHOR
61924-184-162024-12-06C16284748780-1d6a99b39-374c-a426-e053-dadaa90af4c2DERMAPHOR
61924-184-042022-01-28C16284748780-1d6a99b39-374c-a426-e053-dadaa90af4c2DERMAPHOR
61924-184-082022-01-28C16284748780-1d6a99b39-374c-a426-e053-dadaa90af4c2DERMAPHOR
61924-184-162022-01-28C16284748780-1d6a99b39-374c-a426-e053-dadaa90af4c2DERMAPHOR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61924-184-04Dermaphor106 g in 1 TUBEOINTMENT1064
61924-184-08Dermaphor198 g in 1 TUBEOINTMENT1984
61924-184-16Dermaphor454 g in 1 JAROINTMENT4544

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61924-184DERMAPHOR (SKIN PROTECTANT) OINTMENT [DERMARITE INDUSTRIES, LLC]4Legacy NDC, 3 package rows20241208_5bc37618-d27f-6a4d-e053-2991aa0ab247.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61924-184-04GM - Gram61924-184e4420827-31cc-419e-b36a-9631901aca7e12017-11-06
61924-184-08GM - Gram61924-184ae473244-475f-4bd9-b3a1-c99fdb81066712017-11-06
61924-184-16GM - Gram61924-184b55f0207-3df4-4441-b829-f395964c606612017-11-06

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61924-18461924-184-04, 61924-184-08, 61924-184-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
MINERAL OILT5L8T28FGPIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
PARAFFINI9O0E3H2ZEIACT

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-2bc9-5054-e063-6394a90a97555bc37618-d27f-6a4d-e053-2991aa0ab2472024-12-05WarningsExact identifier
spl id: 288a148c-2bc9-5054-e063-6394a90a9755
spl set id: 5bc37618-d27f-6a4d-e053-2991aa0ab247

Reported adverse events (FAERS/openFDA)#

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