NDC 69375-004 Skin Protectant Petrolatum

Petrolatum

NDC Product Code 69375-004

NDC 69375-004-54

Package Description: 454 g in 1 JAR

NDC Product Information

Skin Protectant Petrolatum with NDC 69375-004 is a a human over the counter drug product labeled by Nationwide Pharmaceutical, Llc. The generic name of Skin Protectant Petrolatum is petrolatum. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Nationwide Pharmaceutical, Llc

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.

Skin Protectant Petrolatum 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 44.28 g/100g

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.

  • MINERAL OIL (UNII: T5L8T28FGP)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)

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: Nationwide Pharmaceutical, Llc
Labeler Code: 69375
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: 03-01-2021 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".

* Please review the disclaimer below.

Skin Protectant Petrolatum Product Label Images

Skin Protectant Petrolatum 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

Other

Drug Facts

Active Ingredient

Petrolatum 44.28%

Purpose

Skin protectant

Uses

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

Warnings

For external use only.

When Using This Product

  • Do not get into eyes In case of contact, flush thoroughly with water.

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms last more than 7 days or clear up and occur again within a few days.

Do Not Use On

  • Deep or puncture woundsanimal bitesserious burnsbroken skin

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions

Apply as needed.

Other Information

  • Store at room temperature (59°-86°F)Do not use if inner seal is broken or missing

Inactive Ingredients

Cetostearyl alcohol, microcrystalline wax, mineral oil, and polysorbate 60

* Please review the disclaimer below.