NDC 69423-303 Head And Shoulders Root Rejuvenating Pre-wash Mask

Pyrithione Zinc

NDC Product Code 69423-303

NDC Code: 69423-303

Proprietary Name: Head And Shoulders Root Rejuvenating Pre-wash Mask Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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
  • 69423 - The Procter & Gamble Manufacturing Company
    • 69423-303 - Head And Shoulders Root Rejuvenating Pre-wash Mask

NDC 69423-303-50

Package Description: 40 mL in 1 POUCH

NDC Product Information

Head And Shoulders Root Rejuvenating Pre-wash Mask with NDC 69423-303 is a a human over the counter drug product labeled by The Procter & Gamble Manufacturing Company. The generic name of Head And Shoulders Root Rejuvenating Pre-wash Mask is pyrithione zinc. The product's dosage form is lotion/shampoo and is administered via topical form.

Labeler Name: The Procter & Gamble Manufacturing Company

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 Additional informationCallout TooltipWhat 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 Root Rejuvenating Pre-wash Mask Active Ingredient(s)

Additional informationCallout TooltipWhat 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 1 g/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • GLYCOL DISTEARATE (UNII: 13W7MDN21W)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
  • ZINC CARBONATE (UNII: EQR32Y7H0M)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • 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)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: The Procter & Gamble Manufacturing Company
Labeler Code: 69423
FDA Application Number: part358H Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-08-2019 Additional informationCallout TooltipWhat 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: 12-31-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Head And Shoulders Root Rejuvenating Pre-wash Mask Product Label Images

Head And Shoulders Root Rejuvenating Pre-wash Mask 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 PROCTER & GAMBLE,








CINCINNATI, OH 45202

Active Ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Uses

Helps prevent recurrence of flaking and itching associated with dandruff.

Otc - Do Not Use

For external use only.

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.
  • Gentlly shake before use.wet hair and massage onto scalp, focusing on the roots.rinse well.

Inactive Ingredients

Water, sodium laureth sulfate, cocamide MEA, sodium xylenesulfonate, zinc carbonate, glycol distearate, sodium lauryl sulfate, cocamidopropyl betaine, fragrance, sodium chloride, dimethicone, menthol, guar hydroxypropyltrimoniumchloride, sodium benzoate, stearyl alcohol, magnesium carbonate hydroxide, cetyl alcohol, polyquaternium-76,mentha piperita (peppermint) oil, mentha arvensis leaf oil, melaleuca alternifolia (tea tree) leaf oil, methylchloroisothiazolinone,methylisothiazolinone, yellow 5, blue 1.

* Please review the disclaimer below.

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