NDC 69282-005 Nioxin Scalp Recovery Medicating Cleanser

Pyrithione Zinc

NDC Product Code 69282-005

NDC 69282-005-10

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC 69282-005-20

Package Description: 200 mL in 1 BOTTLE, PLASTIC

NDC 69282-005-50

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

NDC Product Information

Nioxin Scalp Recovery Medicating Cleanser with NDC 69282-005 is a a human over the counter drug product labeled by The Wella Corporation. The generic name of Nioxin Scalp Recovery Medicating Cleanser is pyrithione zinc. The product's dosage form is lotion/shampoo and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1487080 and 209884.

Dosage Form: Lotion/shampoo - A lotion dosage form which has a soap or detergent that is usually used to clean the hair and scalp; it 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.

Nioxin Scalp Recovery Medicating Cleanser 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 LAURETH-3 SULFATE (UNII: BPV390UAP0)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • ZINC CARBONATE (UNII: EQR32Y7H0M)
  • GLYCOL DISTEARATE (UNII: 13W7MDN21W)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
  • SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
  • MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)

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: The Wella Corporation
Labeler Code: 69282
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: 07-01-2016 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".

* Please review the disclaimer below.

Nioxin Scalp Recovery Medicating Cleanser Product Label Images

Nioxin Scalp Recovery Medicating Cleanser 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

Dist. by THE WELLA


CORPORATION, WOODLAND


HILLS, CA 91367

Active Ingredient

Pyrithione Zinc


1%

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

Uses

  • Helps prevent recurrence of flaking, itching, irritation, scaling and redness associated with dandruff and seborrheic dermatitis.

Warnings

For external use only.

Otc - Ask Doctor

Ask a doctor before use if you have a condition that covers a large area of the body.

When Using This Product

  • Avoid contact with 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.

Otc - Keep Out Of Reach Of Children

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 doctor.Use daily for maximum dandruff control.Massage on to wet scalp and hair. Rinse. Repeat if desired.

Inactive Ingredients

WATER, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDE MEA, ZINC CARBONATE, GLYCOL DISTEARATE, DIMETHICONE, CETYL ALCOHOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, SODIUM XYLENESULFONATE, MAGNESIUM SULFATE, SODIUM CHLORIDE, SODIUM BENZOATE, FRAGRANCE, DMDM HYDANTOIN, MENTHA PIPERITA (PEPPERMINT) OIL, MENTHOL, MENTHA ARVENSIS LEAF OIL, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL, CAMELLIA SINENSIS LEAF EXTRACT, YEAST EXTRACT, LECITHIN, SACCHAROMYCES/MAGNESIUM FERMENT, BIOTIN/FOLIC ACID/CYANOCOBALAMIN/NIACINAMIDE/PANTOTHENIC ACID/PYRIDOXINE/RIBOFLAVIN/THIAMINE/YEAST POLYPEPTIDES, SACCHAROMYCES/IRON FERMENT, SACCHAROMYCES/COPPER FERMENT, SACCHAROMYCES/SILICON FERMENT, SACCHAROMYCES/ZINC FERMENT.

Questions?

1-800-935-5273

* Please review the disclaimer below.