NDC 69396-073 Vitamin A And D

Petrolatum

NDC Product Code 69396-073

NDC 69396-073-09

Package Description: 144 PACKET in 1 CARTON > .9 g in 1 PACKET

NDC Product Information

Vitamin A And D with NDC 69396-073 is a a human over the counter drug product labeled by Trifecta Pharmaceuticals Usa Llc. The generic name of Vitamin A And D is petrolatum. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Trifecta Pharmaceuticals Usa 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.

Vitamin A And D 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 93.5 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.

  • CORN OIL (UNII: 8470G57WFM)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • VITAMIN D (UNII: 9VU1KI44GP)

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: Trifecta Pharmaceuticals Usa Llc
Labeler Code: 69396
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: 05-11-2021 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.

Vitamin A And D Product Label Images

Vitamin A And D 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

Petrolatum 93.5%

Purpose

Skin Protectant

Uses

  • Temporarily protects and relievesminor cutsscrapesburnschapped or cracked skin and lips

Stop Use And Ask A Doctor

Condition worsensSymptoms last more than 7 days or clear up and occur again with a few days

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center immediately

When Using This Product

Avoid contact with eyes

Do Not Use

  • On deep or puncture woundsAnimal BitesSerious Burns

Directions

Apply as needed

Inactive Ingredients

Corn oil, light mineral oil, vitamin A Palmitate, vitamin D

Other

Distributed ByTrifecta Pharmaceuticals USA101 NE Third Avenue, Suite 1500Ft. Lauderdale, FL. 33301www.trifecta-pharma.com1-888-296-9067

Warnings

For external use only

Questions

Call: 1-888-296-9067

Storage And Handling

Store at room temperature 20º-25ºC (68º-77ºF)Tamper evident, do not use if packet is torn, cut or openedAvoid excessive heat and humidity

* Please review the disclaimer below.