NDC 71969-111 Diaper

Zinc Oxide

NDC Product Information

Diaper with NDC 71969-111 is a a human over the counter drug product labeled by Medek Laboratories Inc.. The generic name of Diaper is zinc oxide. The product's dosage form is ointment and is administered via topical form.

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.

Diaper 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.


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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • LANOLIN (UNII: 7EV65EAW6H)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
  • TOCOL ACETATE (UNII: 37Z972M0N0)
  • HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
  • PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)
  • BISABOLOL OXIDE A (UNII: 16AE65F94Y)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)

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: Medek Laboratories Inc.
Labeler Code: 71969
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: 03-08-2018 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: 12-31-2021 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 - 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.

Diaper 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

Active Ingredients                                                               PurposeZinc Oxide 12.8%..............................................................Skin Protectant

Purpose

Skin Protectant

Warnings

FOR EXTERNAL USE ONLY

When Using This Product

When using this product keep out of eyes.

Stop Use And Ask A Doctor If

Stop use and ask a doctor if condition worsens or does not improve after 7 days

Keep Out Of Reach Of Children

Keep out of reach of children.

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Petrolatum, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, camellia sinensis leaf extract, tocopheryl acetate, sunflower seed extract, sorbitan oleate, bisabolol, cholesterol

Indications

UsesHelp heal and prevent diaper rashProtects chafed skin due to diaper rash and helps protect wetness

Do Not Use

Discontinue use if irritation occurs.

Ask A Doctor

Ask a doctor if condition worsens

Directions

Change wet and soiled diapers promptlycleanse the diaper areaallow to dryapply ointment liberally as often as necessary with each diaper change and anytime when exposure to wet diapers may be prolonged

Dosage

Apply ointment liberally as often as necessary with each diaper change and anytime when exposure to wet diapers may be prolonged

* Please review the disclaimer below.