NDC 69981-710 Curacid Dermal For Cuts And Burns

Petrolatum, Cod Liver

NDC Product Code 69981-710

NDC 69981-710-04

Package Description: 120 mL in 1 JAR

NDC Product Information

Curacid Dermal For Cuts And Burns with NDC 69981-710 is a a human over the counter drug product labeled by Rev Pharma Corp.. The generic name of Curacid Dermal For Cuts And Burns is petrolatum, cod liver. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Rev Pharma Corp.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Curacid Dermal For Cuts And Burns Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PETROLATUM 300 mg/mL
  • COD LIVER OIL 100 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CHAMOMILE (UNII: FGL3685T2X)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • GREEN OLIVE (UNII: 6HD2W46UEG)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Rev Pharma Corp.
Labeler Code: 69981
FDA Application Number: part347 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Curacid Dermal For Cuts And Burns Product Label Images

Curacid Dermal For Cuts And Burns Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients:

Petrolatum 30.00%Cod Liver Oil 10.00%

Purpose:

Skin Protectant

Uses:

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

Warnings:

  • For external use only.

When Using This Product,

  • Do not get into eyes.If condition worsens or does not improve for seven days, discontinue use and consult a physician.

Do Not Use

IF TAMPER EVIDENT SEAL IS BROKEN.

Keep Out Of Reach Of Children.

If swallowed, contact physician or poison control center immediately.

Other Information:

Store at room temperature.

Directions:

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

Inactive Ingredients:

Beeswax, BHT, Chamomilla Recutita (Chamomile) Oil, Helianthus Annuus (Sunflower) Oil, Oleas Europaea (Olive) Oil y Salvia Hispanica (Chia) Seed Oil.

* Please review the disclaimer below.

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