NDC 36800-069 Pure Petroleum

White Petrolatum

NDC Product Code 36800-069

NDC 36800-069-10

Package Description: 28.3 g in 1 TUBE

NDC 36800-069-27

Package Description: 369 g in 1 JAR

NDC 36800-069-54

Package Description: 106 g in 1 JAR

NDC 36800-069-96

Package Description: 213 g in 1 JAR

NDC Product Information

Pure Petroleum with NDC 36800-069 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Pure Petroleum is white petrolatum. The product's dosage form is jelly and is administered via topical form.

Labeler Name: Topco Associates Llc

Dosage Form: Jelly - A class of gels, which are semisolid systems that consist of suspensions made up of either small inorganic particles or large organic molecules interpenetrated by a liquid--in which the structural coherent matrix contains a high portion of liquid, usually water.

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.

Pure Petroleum 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 1 g/g

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: Topco Associates Llc
Labeler Code: 36800
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: 08-15-1991 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: 12-31-2021 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.

Pure Petroleum Product Label Images

Pure Petroleum 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

White Petrolatum USP (100%)

Purpose

Skin protectant

Uses

  • Temporarily protects minor: cuts, scrapes, burnstemporarily protects and helps relieve chapped or cracked skin and lipshelps protect from the drying effects of wind and cold weather

Warnings

For external use only

When Using This Product

  • Do not get into eyes

See A Doctor If

Condition lasts more than 7 days

Do Not Use

  • Deep or puncture woundsanimal bitesserious burns

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply as needed

Dislcaimer

This product is not manufactured or distributed by Unliever, distributor of Vaseline

Adverse Reactions

DISTRIBUTED BY TOPCO ASSOCIATES LLC7711 GROSS POINT ROADSKOKIE, IL 60077QUESTIONS? 1-888-423-0139topcare@topco.comThis TOP CARE product is laboratory tested to guarantee its highest quality.  Your total satisfaction is guaranteed.Made in USA with US and foreign components.

* Please review the disclaimer below.