NDC 68715-291 Derma Doctor Calm Cool And Corrected

Pyrithione Zinc

NDC Product Code 68715-291

NDC 68715-291-02

Package Description: 1 BOTTLE, GLASS in 1 CARTON > 180 mL in 1 BOTTLE, GLASS (68715-291-01)

NDC Product Information

Derma Doctor Calm Cool And Corrected with NDC 68715-291 is a a human over the counter drug product labeled by Dermadoctor. The generic name of Derma Doctor Calm Cool And Corrected is pyrithione zinc. The product's dosage form is gel and is administered via topical form.

Labeler Name: Dermadoctor

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Derma Doctor Calm Cool And Corrected 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.

  • PYRITHIONE ZINC 2 g/100mL

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 SULFATE (UNII: BPV390UAP0)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • ALLANTOIN (UNII: 344S277G0Z)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: Dermadoctor
Labeler Code: 68715
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: 12-01-2005 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.

Derma Doctor Calm Cool And Corrected Product Label Images

Derma Doctor Calm Cool And Corrected 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

Otc - Active Ingredient

Active IngredientPyrithione Zinc 2%

Otc - Purpose

Purpose: Controls the symptoms of seborrheic dermatitis

Indications

Controls itching, irritation, redness and flaking associated with seborrheic dermatitis.

Warnings

  • For External use only.Avoid contact with the eyes.  If contact occures, rinse eyes thoroughly with water. If condition worsens or does not improve after regular use of this product as directed, consult a physician.If condition covers a large area of the body, consult your doctor before using this product

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

Apply to wet skin.  Create a rich lather using warm water and massage gently.  Rinse well.  For best results use at least twice a week or as directed by a doctor.

Other Ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Peg-7 Glyceryl cocoate, Polyqauternium-7, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, PEG-12 Dimethicone, Sodium Hydroxide, Phenoxyethanol,  Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben.

* Please review the disclaimer below.