NDC 49035-254 Equate Everyday Clean Dandruff Anti-dandruff

Pyrithione Zinc

NDC Product Code 49035-254

NDC Code: 49035-254

Proprietary Name: Equate Everyday Clean Dandruff Anti-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.


Code Structure
  • 49035 - Wal-mart Stores, Inc.
    • 49035-254 - Equate Everyday Clean Dandruff

NDC 49035-254-01

Package Description: 420 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Equate Everyday Clean Dandruff Anti-dandruff with NDC 49035-254 is a a human over the counter drug product labeled by Wal-mart Stores, Inc.. The generic name of Equate Everyday Clean Dandruff Anti-dandruff is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Wal-mart Stores, Inc.

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.


Equate Everyday Clean Dandruff Anti-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.

  • PYRITHIONE ZINC 10 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)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • GLYCOL DISTEARATE (UNII: 13W7MDN21W)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
  • AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 4 (UNII: X3W0AM1JLX)

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: Wal-mart Stores, Inc.
Labeler Code: 49035
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: 01-31-2019 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.

Equate Everyday Clean Dandruff Anti-dandruff Product Label Images

Equate Everyday Clean Dandruff Anti-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

Other

Drug Facts

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716

Active Ingredient

Pyrithione Zinc 1%

Purpose

Anti-dandruff

Use

Helps prevent recurrence of flaking and itching associated with dandruff

Warnings

For external use only

When Using This Product

  • ♦do not get into 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 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 right away.

Directions

  • ♦shake well ♦wet hair ♦massage onto scalp ♦rinse♦repeat if desired ♦for best results use at least twice a week or as directed by a doctor♦for maximum dandruff control, use every time you shampoo

Other Information

Store at room temperature

Inactive Ingredients

Water, sodium laureth sulfate, cocamide MEA, sodium lauryl sulfate, glycol distearate, dimethicone, fragrance, cetyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, benzyl alcohol, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, citric acid, blue 1, red 4

* Please review the disclaimer below.

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