NDC 0096-0738 Dhs Sal 4 Oz.

Dhs Sal

NDC Product Information

Dhs Sal 4 Oz. with NDC 0096-0738 is a a human over the counter drug product labeled by Person And Covey. The generic name of Dhs Sal 4 Oz. is dhs sal. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Person And Covey

Dosage Form: Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.

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.

Dhs Sal 4 Oz. 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 .035 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.

  • WATER (UNII: 059QF0KO0R)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
  • PEG-8 DISTEARATE (UNII: 7JNC8VN07M)

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: Person And Covey
Labeler Code: 0096
FDA Application Number: part333D 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: 06-01-1995 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’.

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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]

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Dhs Sal 4 Oz. 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

Warnings And Precautions

For external use only. Ask a physician before use if you have Psoriasis or Seborrheic Dermatitis that covers a large area of the body. Do not get into eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a physician if condition worsens or does not improve after regular use.

Dosage And Administration

Shake well before using.  Wet hair thoroughly. Apply a liberal amount of shampoo and massage into a rich lather. Allow lather to remain on scalp for several minutes. Rinse hair well and repeat application. For best results use at least twice a week or as directed by a physician.

Indications And Use

Helps prevent recurrence of scalp itching and flaking associated with Seborrheic Dermatitis and Dandruff.

Otc - Keep Out Of Reach Of Children

Yes.  If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Recommended for control of Dandruff of Seborrheic Dermatitis

Inactive Ingredients

Purified WaterTEA Lauryl SulfateCocamidopropyl HydroxysultaineSodium ChloridePEG 8 DistearateMethocel E4M PremiumVeegumHerbal Bouquet No. 1751 PerfumeFD&C Yellow No.6

Active Ingredient

Pyrithione zinc

* Please review the disclaimer below.