NDC 0093-3204 Moisturel

Dimethicone

NDC Product Code 0093-3204

NDC Product Information

Moisturel with NDC 0093-3204 is a a human over the counter drug product labeled by Teva Pharmaceuticals Usa, Inc.. The generic name of Moisturel is dimethicone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Teva Pharmaceuticals Usa, Inc.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Moisturel 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.

  • DIMETHICONE 30 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.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LAURETH-23 (UNII: N72LMW566G)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • STEARETH-2 (UNII: V56DFE46J5)
  • WATER (UNII: 059QF0KO0R)

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: Teva Pharmaceuticals Usa, Inc.
Labeler Code: 0093
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: 11-12-2018 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.

Moisturel Product Label Images

Moisturel 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

Dimethicone 3%

Purpose

Skin Protectant

Uses

  • Temporarily protects and helps prevent chafed, chapped, cracked or windburned skin.helps treat and prevent minor skin irritation due to diaper rash.helps seal out wetness in the diaper area.

Warnings

  • For external use only.

When Using This Product

  • Avoid contact with the eyes.not to be applied over puncture wounds.not to be applied over infections.

Stop Using This Product And Ask A Doctor

  • If condition worsens or does not improve within 7 days.

Directions

  • For skin protectant use apply liberally as often as needed.for diaper rash use:  • change wet diapers promptly. • cleanse the diaper area and allow to dry. • apply lotion liberally with each changing.

Inactive Ingredients:

Benzyl alcohol, carbomer, cetyl alcohol, glycerin, laureth-23, magnesium aluminum silicate, petrolatum, potassium sorbate, sodium hydroxide, steareth-2, water

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday - Friday.

Other

Quick absorbing, long lasting Moisturel® leaves skin feeling smooth and soft. Clinically proven, this skin protectant relieves dry skin and is designed not to clog pores. Free of lanolins and parabens that can irritate sensitive skin.

* Please review the disclaimer below.

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