FDA.reportPublic FDA data

Curefini Dermal Ointment

Manufacturer
Rev Pharma Corp
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:58:56

Label at a glance#

ProductCurefini Dermal
Active ingredientPETROLATUM, COD LIVER OIL
Label structure9 sections

Indications and uses

Temporarily protects minor cuts, scrapes and burns. Temporarily protects chappped or cracked skin. Helps protect from drying effects of wind and cold weather.

Dosage and administration

Apply as needed. Prepare a gauze bandaage to apply. Dressing should be placed on a clean and flat surface. Apply ointment with a spatula, covering the entire sufrace with a thin layer. Place bandage directly on top of affected area. Make sure afffected area remains covered by ointment.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 30.00%, Cod Liver Oil 10.00%

OTC - PURPOSE SECTION

(Skin Protectant)

Uses:

INDICATIONS & USAGE SECTION

  • Temporarily protects minor cuts, scrapes and burns.
  • Temporarily protects chappped or cracked skin.
  • Helps protect from drying effects of wind and cold weather.

Warnings:

WARNINGS SECTION

  • For external use only.

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes. 

  • If condition woresens or does not improve for seven days, discontinue use and consult a physician.

DO NOT USE

OTC - DO NOT USE SECTION

  • IF TAMPER EVIDENT SEAL IS BROKEN.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, contact physician or poison control center immediately.

Other information:

SPL UNCLASSIFIED SECTION

Store at room temperature.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply as needed. Prepare a gauze bandaage to apply. Dressing should be placed on a clean and flat surface. Apply ointment with a spatula, covering the entire sufrace with a thin layer. Place bandage directly on top of affected area. Make sure afffected area remains covered by ointment.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Beeswax, BHT Chammomilla Recutita (Chammoile)oil, Helianthus Annuus (Sunflower) Oil, Prunus Amgdalus Dulcis (Sweet Almond) Oil.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3344

Package Labeling:69981-754-30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling:69981-754-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1440007petrolatum 30 % / cod liver oil 10 % Topical OintmentPSN8
1440007cod liver oil 0.1 MG/MG / petrolatum 0.3 MG/MG Topical OintmentSCD8
1440007cod liver oil 10 % / petrolatum 30 % Topical OintmentSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69981-754-01Curefini Dermal120 mL in 1 JAROINTMENT1208
69981-754-02Curefini Dermal240 mL in 1 JAROINTMENT2408
69981-754-03Curefini Dermal30 mL in 1 JAROINTMENT308
69981-754-04Curefini Dermal60 mL in 1 JAROINTMENT608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69981-754CUREFINI DERMAL (PETROLATUM, COD LIVER) OINTMENT [REV PHARMA CORP]8Legacy NDC, 4 package rows20231106_44cd54a7-164b-4006-813d-9e2191e8d0e7.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69981-75469981-754-01, 69981-754-02, 69981-754-04, 69981-754-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CHAMOMILEFGL3685T2XIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
ALMOND OIL66YXD4DKO9IACT
PETROLATUM4T6H12BN9UACTIB
COD LIVER OILBBL281NWFGACTIB

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
5b37c36a-19bf-a54d-e063-6294a90a0ec844cd54a7-164b-4006-813d-9e2191e8d0e72026-09-11WarningsExact identifier
spl set id: 44cd54a7-164b-4006-813d-9e2191e8d0e7

Reported adverse events (FAERS/openFDA)#

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