NDC 11527-478 Dr. Sheffield Psoriasis Medicated Moisturizer

Psoriasis Medicated Moisturizer

NDC Product Code 11527-478

NDC CODE: 11527-478

Proprietary Name: Dr. Sheffield Psoriasis Medicated Moisturizer What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Psoriasis Medicated Moisturizer What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 11527 - Sheffield Pharmaceuticals Llc
    • 11527-478 - Dr. Sheffield Psoriasis Medicated Moisturizer

NDC 11527-478-64

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

NDC Product Information

Dr. Sheffield Psoriasis Medicated Moisturizer with NDC 11527-478 is a a human over the counter drug product labeled by Sheffield Pharmaceuticals Llc. The generic name of Dr. Sheffield Psoriasis Medicated Moisturizer is psoriasis medicated moisturizer. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Sheffield Pharmaceuticals Llc

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.

Dr. Sheffield Psoriasis Medicated Moisturizer 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.

  • SALICYLIC ACID 20 mg/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.

  • WATER (UNII: 059QF0KO0R)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CARBOMER 934 (UNII: Z135WT9208)
  • ZINC PIDOLATE (UNII: C32PQ86DH4)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
  • ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • RHEUM PALMATUM ROOT (UNII: G025DAL7CE)
  • ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • OLIVE OIL (UNII: 6UYK2W1W1E)

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: Sheffield Pharmaceuticals Llc
Labeler Code: 11527
FDA Application Number: part358H 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: 09-01-2013 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".

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Information for Patients

Salicylic Acid Topical

Salicylic Acid Topical is pronounced as (sal'' i sil' ik as' id)

Why is salicylic acid topical medication prescribed?
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions ...
[Read More]

* Please review the disclaimer below.

Dr. Sheffield Psoriasis Medicated Moisturizer 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

Salicylic Acid -2%

Purposes

Psoriasis and seborrheic dermatitis

Uses

  • Relieves and helps prevent recurrence ofitchingirrationrednessflaking and scaling due to psoriasis and seborrheic dermatitis

Warnings

For external use onlyAsk A doctor before use if condition covers a large area of the body.When using this product avoid contact with eyes. if contact occurs, rinse throughly with water.Stop use and ask a doctor if condition worsens or does not improve after regular use.

Directions

Apply to affected areas one to four times daily or as directed by a doctor.

Other Information

Store at a controlled room temperature 68°-77°F ( 20°- 25°C)Questions? 1-800-222-1087

Inactive Ingredients

Purifed Water, Caprylic/Capric Triglyceride, Mineral Oil, Cetyl Alcohol, Butylene Glycol, Stearic Acid, Sodium Citrate, Glyceral Stearate, Triethanolamine, PEG-100 Sterate, Polysorbate 60 , Phenoxyethanol, Carbomer, Zinc PCA, Panthenol, Camellia Oleifera leaf extract , Algea Extract, Artemisia Vulgaris Extract, Dipotassium Glycyrrhizate, Disodium EDTA, Rheum Palmatum Extract, Rosa Damascena Extract, Citric Acid, Methylparaben, Propylparaben, Dimethicone, Extra Virign Olea Europaea( Olive) Fruit oil

* Please review the disclaimer below.