NDC 41163-296 Dry Scalp Care

Pyrithione Zinc

NDC Product Code 41163-296

NDC 41163-296-15

Package Description: 420 mL in 1 BOTTLE, PLASTIC

NDC 41163-296-35

Package Description: 700 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Dry Scalp Care with NDC 41163-296 is a a human over the counter drug product labeled by Unfi. The generic name of Dry Scalp Care is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Unfi

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.

Dry Scalp Care 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 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)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

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: Unfi
Labeler Code: 41163
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: 01-19-2015 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.

Dry Scalp Care Product Label Images

Dry Scalp Care 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

EQUALINEDry Scalp2 In 1Dandruff Shampoo& Conditioner

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

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 chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, Prunus amygdalus dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone

Disclaimer

This product is not manufactured or distributed by Procter & Gamble, distributor of Heard & Shoulders Dry Scalp Care Dandruff Shampoo & Conditioner.

Adverse Reactions Section

DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344 USAWe're committed to your satisfaction and guarantee the quality of this product.  Contact us at 1-877-932-7948, or www.supervalu-ourownbrands.com.Please have package available.296.007/296AT

* Please review the disclaimer below.