NDC 69396-021 Zinc Oxide 20%

Zinc Oxide

NDC Product Code 69396-021

NDC 69396-021-01

Package Description: 1 TUBE in 1 BOX > 28 g in 1 TUBE

NDC 69396-021-02

Package Description: 1 TUBE in 1 BOX > 60 g in 1 TUBE

NDC 69396-021-54

Package Description: 1 JAR in 1 JAR > 454 g in 1 JAR

NDC Product Information

Zinc Oxide 20% with NDC 69396-021 is a a human over the counter drug product labeled by Trifecta Pharmaceuticals Usa. The generic name of Zinc Oxide 20% is zinc oxide. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Trifecta Pharmaceuticals Usa

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.

Zinc Oxide 20% 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.

  • ZINC OXIDE .2 g/g
  • ZINC OXIDE .2 g/g
  • ZINC OXIDE .2 g/g

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)
  • PETROLATUM (UNII: 4T6H12BN9U)

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.
  • 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
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: 01-04-2018 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: 12-31-2019 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.

Zinc Oxide 20% 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

Zinc Oxide 20%

Purpose

Skin Protectant

Uses

  • Protects skinProtects and releives chafed skin due to diaper rash - helps seal out wetnessDries the oozing and weeping of poison ivy, oak and sumac

Keep Out Of The Reach Of Children

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

Warnings

  • For External Use OnlyWhen using this product avoid contact with eyesStop use and ask a doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.

Directions

  • Apply ointment liberally as often as necessaryFor the treatment of diaper rash, change wet and soiled diapers promptlyCleanse the diaper area and allow to dryApply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged

Other Information

  • Store at controlled room temperature 15° - 30°C (59° - 86°F)

Inactive Ingredients

Mineral Oil, Petrolatum

Distributed By:

Trifecta Pharmaceuticals USA, LLC.101 NE Third Avenue, Ste. 1500Ft. Lauderdale, FL. 33301, USA.Product of PRCwww.trifecta-pharma.com

* Please review the disclaimer below.