NDC 33992-0498 Petrolatum

Petrolatum

NDC Product Code 33992-0498

NDC 33992-0498-1

Package Description: 85 g in 1 TUBE

NDC Product Information

Petrolatum with NDC 33992-0498 is a a human over the counter drug product labeled by Greenbrier International, Inc.. The generic name of Petrolatum is petrolatum. The product's dosage form is cream and is administered via topical form.

Labeler Name: Greenbrier International, Inc.

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.

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 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)

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: Greenbrier International, Inc.
Labeler Code: 33992
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: 05-17-2019 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.

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

Active Ingredient:

White Petrolatum USP (30 %)

Purpose

Skin protectant

Uses

  • Temporarily protects minor:cuts
  • Scrapes
  • Burns
  • Temporarily protects and helps relieve chapped or cracked skin
  • Helps protect from the drying effects of wind and cold weather

Warnings

For external use only.Do not use on deep puncture wounds, animal bites and serious burns.

When Using This Product,

Do not get into eyes

Stop Use And Ask Doctor If

  • Condition worsens,
  • Symptoms last more than 7 days
  • Clear up and occur again within a few days

Keep Out Of Reach Of Children.

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

Directions

Apply as needed.

Inactive Ingredients

Water (aqua), glycerin, glyceryl monostearate, PEG-100 stearate, stearic acid, ceteareth 20, trieathanolamine, lanolin alcohol, fragrance, acrylates/C 10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, cocoa butter, tocopheryl acetate, disodium EDTA
110781 DISTRIBUTED BYGREENBRIER INTERNATIONAL, INC.500 VOLVO PARKWAY,CHESAPEAKE, VA 23320MADE IN INDIASkin SoftenerHydrates &Evens Skin ToneCOCOABUTTERPetroleum JellyC. No. DNH/COS/DNH/1301222101976

* Please review the disclaimer below.

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