NDC 50594-153 Everyday Clean Dandruff

Pyrithione Zinc

NDC Product Code 50594-153

NDC 50594-153-35

Package Description: 700 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Everyday Clean Dandruff with NDC 50594-153 is a a human over the counter drug product labeled by Big Lots. The generic name of Everyday 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 a single RxCUI concept is associated to this product: 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.

Everyday 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 SULFATE (UNII: BPV390UAP0)
  • GLYCOL DISTEARATE (UNII: 13W7MDN21W)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • ZINC CARBONATE (UNII: EQR32Y7H0M)
  • SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
  • AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
  • MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • 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: Big Lots
Labeler Code: 50594
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: 04-29-2015 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: 12-31-2022 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".

* Please review the disclaimer below.

Everyday Clean Dandruff Product Label Images

Everyday 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

Claims

  • EVERYDAY CLEANDandruff ShampooMultiple benefit formula to help:Fight dry scalpCalm itchRelieve irritationSoothe and reduce rednessReduce oilinessPrevent flakesLeave hair healthy looking

Active Ingrediet

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

Keep Out Of Reach Of Children

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

Directions

  • Shake wellfor maximum dandruff control, use every time you shampoowet hair, massage onto scalp, rinse, repeat if desiredfor best results use at least twice a week or as directed by a doctor

Inactive Ingredients

Water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chlorde, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltimonium chloride, magnesium carbonate hydroxie, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

Questions

Call 1-888-593-0593

Disclaimer

This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders Classic Clean Dandruff Shampoo

Adverse Reactions

Manufactures by: Vi-Jon for Big Lots8515 Page Avenue; St. Louis, MO 63114MADE IN USA WITH US AND FOREIGN COMPONENTS153.008/153AZ

* Please review the disclaimer below.