NDC 67751-053 Head And Shoulders Classic Clean Dandruff

Pyrithione Zinc

NDC Product Code 67751-053

NDC CODE: 67751-053

Proprietary Name: Head And Shoulders Classic Clean Dandruff 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: Pyrithione Zinc 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

  • 67751 - Navajo Manufacturing Company Inc
    • 67751-053 - Head And Shoulders Classic Clean Dandruff

NDC 67751-053-01

Package Description: 1 BOTTLE in 1 CARTON > 50 mL in 1 BOTTLE

NDC Product Information

Head And Shoulders Classic Clean Dandruff with NDC 67751-053 is a a human over the counter drug product labeled by Navajo Manufacturing Company Inc. The generic name of Head And Shoulders Classic Clean Dandruff is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1043244 and 209884.

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.

Head And Shoulders Classic Clean Dandruff 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.


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 LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
  • GLYCOL DISTEARATE (UNII: 13W7MDN21W)
  • ZINC CARBONATE (UNII: EQR32Y7H0M)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
  • MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)

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: Navajo Manufacturing Company Inc
Labeler Code: 67751
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: 05-31-2013 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

Selenium Sulfide

Selenium Sulfide is pronounced as (se lee' nee um)

Why is selenium sulfide medication prescribed?
Selenium sulfide, an anti-infective agent, relieves itching and flaking of the scalp and removes the dry, scaly particles that are commonly referred to as dandruff or seb...
[Read More]

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Head And Shoulders Classic Clean Dandruff Product Label Images

Head And Shoulders Classic Clean Dandruff 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 Ingredients

Pyrithione zinc 1%

Purpose

Anti-dandruff

Uses

Helps prevent recurrence of flaking and itching associated with dandruff

Warnings

For external use only

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

Keep This And All Drugs Out Of Reach Of Children.

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

Directions

  • For best results use at least twice a week or as directed by a doctorfor maximum dandruff control, use every time you shampoowet hair, massage onto scalp, rinse, repeat if desired.

Inactive Ingredients

Water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, zinc carbonate, sodium chloride, sodium xylenesulfonate, cocamidopropyl betaine, fragrance, dimethicone, sodium benzoate, guar  hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

Head And Shoulders

Www.headandshoulders.comHandy Solutions Guarantee  If dissatisfied with this product, return it with a brief explanation to the address below. We'll replace it free of charge and refund your postage. You may also call 1-800-525-5097 for customer service, 9am to 4 pm MST, weekdays or email us at [email protected] Visits us on the web at www.navajomfg.comLarry Rupp  President  Gordon Levy  CEORepacked with permission of manufactured by: Procter and Gamble Cincinnati, OH 45202  Handy Solutions A Trademark of Navajo Mfg. Co. Inc. 5330 Fox Street Denver, CO 80216  Made in USA

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