NDC 73314-003 Little Twig Diaper Rash Cream

Diaper Cream Ointment

NDC Product Code 73314-003

NDC Product Information

Little Twig Diaper Rash Cream with NDC 73314-003 is a a human over the counter drug product labeled by Kittrich Corporation. The generic name of Little Twig Diaper Rash Cream is diaper cream ointment. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Kittrich Corporation

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.

Little Twig Diaper Rash Cream 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 14 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 WAX (UNII: 7G1J5DA97F)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • SHEA BUTTER (UNII: K49155WL9Y)

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: Kittrich Corporation
Labeler Code: 73314
FDA Application Number: part352 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: 02-07-2020 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.

Little Twig Diaper Rash Cream Product Label Images

Little Twig Diaper Rash Cream 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

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Formulated with organic coconut oil and zinc oxide, Little Twig Diaper Cream gently soothes skin while creating a protective barrier to seal out wetness and heal irritated skin.

Questions Call 1.866.545.8944FREE FROM: Parabens, Silicone, Pthalates, Artificial Fragrances & Dyeslittletwig.com 1.866.lil.twigKittrich CorporationPOMONA, CA 91766(c) 2020. All rights reserved.MADE IN USA

Active Ingredient

Active Ingredient: Zinc Oxide 14%

Purpose

Purpose Skin Protectant

Indications & Usage

Uses:Helps treat and prevent diaper rash, protects chafed skin due to diaper rash and helps seal out wetness.

Warnings

Warnings: For external use only. When using this product do not get into eyes.

Stop Use

Stop use and ask a doctor if condition worsens or symptoms last more than 7 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

Directions: Change wet or soiled diaper immediately. Apply cream liberally and as often as necessary with each diaper change.

Inactive Ingredients

Healianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Oil, Cera Alba (Beeswax), Cocos Nucifera (Coconut) Oil*, Butyrosperumum Parkii (Shea) Butter, Tocopherol
*CERTIFIED ORGANIC INGREDIENT

* Please review the disclaimer below.