NDC 69981-194 Curefini Skin Protection Cream

Petrolatum

NDC Product Code 69981-194

NDC 69981-194-01

Package Description: 30 mL in 1 JAR

NDC 69981-194-02

Package Description: 60 mL in 1 JAR

NDC 69981-194-04

Package Description: 120 mL in 1 JAR

NDC 69981-194-08

Package Description: 240 mL in 1 JAR

NDC Product Information

Curefini Skin Protection Cream with NDC 69981-194 is a a human over the counter drug product labeled by Rev Pharma Corp. The generic name of Curefini Skin Protection Cream is petrolatum. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1043075.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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.

Curefini Skin Protection Cream 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.


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.

  • WATER (UNII: 059QF0KO0R)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • CHAMOMILE (UNII: FGL3685T2X)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • COD LIVER OIL (UNII: BBL281NWFG)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: 07-12-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Curefini Skin Protection Cream Product Label Images

Curefini Skin Protection Cream 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 Ingredient:

Petrolatum 30.00%

Porpose:

Skin Protectant

Uses:

  • For the temporary protection of minor cuts, scrapes and burns.For temporary protection of cracked and chapped skin.Helps protect from the drying effects of wind and cold weather.

Warnings:

For external use only. •Avoid contact with eyes. • 
If symptoms persist for more than seven days, discontinue use and consult a physician.

Keep Out Of Reach Of Children.

  • If swallowed, consult physician.

Do Not Use

  • If tamper evident seal is broken.

Directions:

Apply daily over the affected area, with soft massages to ease absorption. Repeat application as many times as needed to keep skin permanently moisturized.

Other Information:

  • Store at room temperature.Do not use if tamper evident seal is broken.

Inactive Ingredients:

Aqua (Deionized Water), Beeswax, Cetearyl Alcohol, Cetearyl Olivate, Cetearyl Glucoside, Chamomilla Recutitta (Chamomile) Extract, Chamomilla Recutitta (Chamomile) Oil, Cocamidopropyl Betaine, Ethylhexylglycerin, Gadi Lecur (Cod Liver) Oil, Helianthus Annuus (Sunflower) Seed Oil, Phenoxyethanol, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E).

Questions?

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