NDC 72197-014 Pharmacys Prescription 4.5 Oz Cocoa Butter Petroleum Jelly

White Petrolatum

NDC Product Code 72197-014

NDC Code: 72197-014

Proprietary Name: Pharmacys Prescription 4.5 Oz Cocoa Butter Petroleum Jelly What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: White Petrolatum What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 72197 - American Consumer Products Corp
    • 72197-014 - Pharmacys Prescription 4.5 Oz Cocoa Butter Petroleum Jelly

NDC 72197-014-04

Package Description: 127.57 g in 1 TUBE

NDC Product Information

Pharmacys Prescription 4.5 Oz Cocoa Butter Petroleum Jelly with NDC 72197-014 is a a human over the counter drug product labeled by American Consumer Products Corp. The generic name of Pharmacys Prescription 4.5 Oz Cocoa Butter Petroleum Jelly is white petrolatum. The product's dosage form is jelly and is administered via topical form.

Labeler Name: American Consumer Products Corp

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.

Pharmacys Prescription 4.5 Oz Cocoa Butter Petroleum Jelly 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 30 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.

  • WATER (UNII: 059QF0KO0R)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • LAURETH-20 (UNII: 6SU0SC83AH)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: American Consumer Products Corp
Labeler Code: 72197
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: 09-16-2019 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.

Pharmacys Prescription 4.5 Oz Cocoa Butter Petroleum Jelly Product Label Images

Pharmacys Prescription 4.5 Oz Cocoa Butter Petroleum Jelly 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

Active ingredient:Petrolatum 30%

Purpose

Purpose:Skin ProtectantUses:Temporarily protects minor cuts, scrapes burnsTemporarily protects and helps relieve chapped or cracked skinHelps protect from the drying effects of wind and cold weather

Warnings

WarningsFor external use only

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

INACTIVE INGREDIENTS: Water (aqua), Mineral Oil, Glycerin, Cetearyl Alcohol, Cetyl Alcohol, Stearyl Alcohol, Glyceryl Stearate, Fragrance, Polysorbate 80, Laureth-20, BHT, Methylparaben, Propylparaben, Dimethicone, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.

Directions

Directions apply as needed.

Instructions For Use

Do not use on deep puncture wounds, animal bites, serious burns.

Stop Use And Ask A Doctor

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Indications & Usage

When using this product do not get into eyes.

* Please review the disclaimer below.