FDA.reportPublic FDA data

DermaCerin

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#

ProductDermaCerin
Active ingredientPETROLATUM
Label structure12 sections

Indications and uses

Temporarily protects and helps relieve dry, chapped, or cracked skin. Helps protect skin from the drying effects of wind and cold weather.

Dosage and administration

Apply as needed or as directed by a physician.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 33%

Purpose:

OTC - PURPOSE SECTION

Skin Protectant

Uses:

INDICATIONS & USAGE SECTION

  • Temporarily protects and helps relieve dry, chapped, or cracked skin.
  • Helps protect skin from the drying effects of wind and cold weather.

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 - 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.

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

​Directions:

DOSAGE & ADMINISTRATION SECTION

Apply 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

Water, Mineral Oil, Paraffin, Lanolin Alcohol, PEG-30 Dipolhydroxystearate, DMDM Hydantoin, Methylparaben, Propylparaben, Propylene Glycol, Sodium Chloride

​Questions?

OTC - QUESTIONS SECTION

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

DermaCerin Package Label and Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage LabelCarton LabelCarton LabelPackage LabelPackage Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61924-174-042026-01-29C16284748780-11030e365-1167-111a-e063-dadaa90a10e2DermaCerin
61924-174-082026-01-29C16284748780-11030e365-1167-111a-e063-dadaa90a10e2DermaCerin
61924-174-162026-01-29C16284748780-11030e365-1167-111a-e063-dadaa90a10e2DermaCerin
61924-174-042024-12-06C16284748780-11030e365-1167-111a-e063-dadaa90a10e2DermaCerin
61924-174-082024-12-06C16284748780-11030e365-1167-111a-e063-dadaa90a10e2DermaCerin
61924-174-162024-12-06C16284748780-11030e365-1167-111a-e063-dadaa90a10e2DermaCerin
61924-174-042024-01-30C16284748780-11030e365-1167-111a-e063-dadaa90a10e2DermaCerin
61924-174-082024-01-30C16284748780-11030e365-1167-111a-e063-dadaa90a10e2DermaCerin
61924-174-162024-01-30C16284748780-11030e365-1167-111a-e063-dadaa90a10e2DermaCerin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61924-174-04DermaCerin106 g in 1 TUBEOINTMENT1064
61924-174-08DermaCerin198 g in 1 TUBEOINTMENT1984
61924-174-16DermaCerin454 g in 1 JAROINTMENT4544

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61924-174DERMACERIN (SKIN PROTECTANT) OINTMENT [DERMARITE INDUSTRIES, LLC]4Legacy NDC, 3 package rows20241208_5bc3f8a4-a04d-f0c7-e053-2a91aa0a22c4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61924-174-04GM - Gram61924-174fa1d5cb2-df3a-443f-a72b-0784c1c3ba3b12025-07-08

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
61924-17461924-174-04, 61924-174-08, 61924-174-16

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
PARAFFINI9O0E3H2ZEIACT
PROPYLENE GLYCOL 2-(2-METHYLBUTYRATE)3Z73C506A9IACT
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UACTIB
SODIUM CHLORIDE451W47IQ8XIACT
PROPYLPARABENZ8IX2SC1OHIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
MINERAL OILT5L8T28FGPIACT
DMDM HYDANTOINBYR0546TOWIACT
METHYLPARABENA2I8C7HI9TIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT

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
2887f435-7025-b99e-e063-6394a90a125c5bc3f8a4-a04d-f0c7-e053-2a91aa0a22c42024-12-05WarningsExact identifier
spl id: 2887f435-7025-b99e-e063-6394a90a125c
spl set id: 5bc3f8a4-a04d-f0c7-e053-2a91aa0a22c4

Reported adverse events (FAERS/openFDA)#

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