NDC 0295-9011 Hydrolatum

White Petrolatum

NDC Product Code 0295-9011

NDC 0295-9011-13

Package Description: 57 g in 1 TUBE

NDC 0295-9011-36

Package Description: 454 g in 1 JAR

NDC Product Information

Hydrolatum with NDC 0295-9011 is a a human over the counter drug product labeled by Denison Pharmaceuticals, Llc. The generic name of Hydrolatum is white petrolatum. The product's dosage form is cream and is administered via topical form.

Labeler Name: Denison Pharmaceuticals, Llc

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.

Hydrolatum 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 45 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)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • METHYLPARABEN (UNII: A2I8C7HI9T)

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.
  • 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: Denison Pharmaceuticals, Llc
Labeler Code: 0295
FDA Application Number: part346 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: 02-19-2020 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.

Hydrolatum Product Label Images

Hydrolatum 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

Otc - Active Ingredient

White Petrolatum, 54%

Otc - Purpose

Skin Protectant

Indications & Usage

  • Temporarily protects and helps relieve chapped or cracked skinhelps prevent and protect from the drying effects of wind and cold weather

Warnings

  • For external use onlyKeep out of reach of childrenStop using if allergic

Otc - When Using

  • Do not get into eyesdo not get into mouth

Otc - Stop Use

  • If condition lasts more than 7 days

Dosage & Administration

  • Apply as needed

Other Safety Information

  • Store at 20-25C (68-77F)

Inactive Ingredient

Methylparaben, Purified Water, Sorbitan Sesquioleate

Troubleshooting

Call Toll Free at 1-800-601-3843 or email complaints@dpharm.net

Otc - Do Not Use

  • Deep or punctured woundsanimal bitesserious burns

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

* Please review the disclaimer below.