NDC 16864-021 Triple Diaper Rash

Zinc Oxide

NDC Product Code 16864-021

NDC 16864-021-01

Package Description: 1 TUBE in 1 CARTON > 57 g in 1 TUBE

NDC 16864-021-02

Package Description: 1 TUBE in 1 CARTON > 85 g in 1 TUBE

NDC 16864-021-03

Package Description: 227 g in 1 JAR

NDC 16864-021-04

Package Description: 283 g in 1 JAR

NDC 16864-021-05

Package Description: 454 g in 1 JAR

NDC Product Information

Triple Diaper Rash with NDC 16864-021 is a a human over the counter drug product labeled by Advantice Health, Llc. The generic name of Triple Diaper Rash is zinc oxide. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Advantice Health, 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.

Triple Diaper Rash 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 12.8 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.

  • WHITE PETROLATUM (UNII: B6E5W8RQJ4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • LANOLIN (UNII: 7EV65EAW6H)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • OAT (UNII: Z6J799EAJK)

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: Advantice Health, Llc
Labeler Code: 16864
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: 05-15-2021 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".

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Triple Diaper Rash Product Label Images

Triple Diaper Rash 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

Other

Drug Facts

Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927

Active Ingredient

Zinc oxide 12.8%

Purpose

Skin protectant

Uses

  • Helps treat and prevent diaper rashprotects chafed skin due to diaper rash and helps protect from wetness

Warnings

For external use only

Otc - When Using

When using this product do not get into eyes.

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms last more than 7 days or clear up and occur again within a few days.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Change wet and soiled diapers promptlycleanse the diaper area and allow skin to dryapply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any lime exposure to wet diapers may be prolonged

Other Information

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

Inactive Ingredients

White petrolatum, com starch, anhydrous lanolin, stearyl alcohol, beeswax, bisabolol, cholesterol, water, glycerin, oat (avena saliva) kernel extract.

Questions?

1-800-345-0032

* Please review the disclaimer below.