NDC 70000-0532 Leader Maximum Strength Therapeutic T Plus Anti-dandruff, Anti-seborrheic Dematitis And Anti-psoriasis

Salicylic Acid

NDC Product Information

Leader Maximum Strength Therapeutic T Plus Anti-dandruff, Anti-seborrheic Dematitis And Anti-psoriasis with NDC 70000-0532 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Leader Maximum Strength Therapeutic T Plus Anti-dandruff, Anti-seborrheic Dematitis And Anti-psoriasis is salicylic acid. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Cardinal Health

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.

Leader Maximum Strength Therapeutic T Plus Anti-dandruff, Anti-seborrheic Dematitis And Anti-psoriasis 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 30 mg/mL

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 LAURETH-3 SULFATE (UNII: BPV390UAP0)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Cardinal Health
Labeler Code: 70000
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: 10-10-2019 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: 12-31-2020 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.

Leader Maximum Strength Therapeutic T Plus Anti-dandruff, Anti-seborrheic Dematitis And Anti-psoriasis Product Label Images

Leader Maximum Strength Therapeutic T Plus Anti-dandruff, Anti-seborrheic Dematitis And Anti-psoriasis 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 CARDINAL HEALTH DUBLIN, OHIO 43017

Active Ingredient

Salicylic Acid 3.0%

Purpose

Anti-dandruff, anti-seborrheic dermatitis and anti-psoriasis

Uses

  • Control the symptoms of⬥dandruff⬥seborrheic dermatitis⬥psoriasis

Warnings

For external use only

Otc - Ask Doctor

Ask a doctor before use if you have a condition which covers a large part of the body.

When Using This Product

  • ⬥avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor If

  • ⬥condition worsens or does not improve after regular use of this product as directed.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • ⬥for best results use at least twice a week or as directed by a doctor⬥wet hair thoroughly⬥massage shampoo into scalp⬥lather, leave on hair and scalp for several minutes⬥rinse and repeat.

Other Information

  • ⬥store at room temperature⬥store away from direct sunlight.

Inactive Ingredients

Water, sodium laureth sulfate, cocamidopropyl betaine, cocamide MEA, sodium C14-16 olefin sulfonate, polyquaternium-7, propylene glycol, PEG-150 distearate, sodium citrate, triethanolamine.

* Please review the disclaimer below.