NDC 51870-007 Elementz

Pyrithione Zinc

NDC Product Code 51870-007

NDC Product Information

Elementz with NDC 51870-007 is a a human over the counter drug product labeled by Keefe Group. The generic name of Elementz is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Keefe Group

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.

Elementz 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 1 g/100mL

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.

  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • COCO DIETHANOLAMIDE (UNII: 92005F972D)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
  • MAGNESIUM NITRATE (UNII: 77CBG3UN78)

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: Keefe Group
Labeler Code: 51870
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: 06-10-2019 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.

Elementz Product Label Images

Elementz 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: Keefe Supply CompanyBridgeton, MO 63044800-325-8998Made in Colombia

Otc - Active Ingredient

Active ingredientPyrithione zinc 1%

Otc - Purpose

PurposeAntidandruff shampoo

Indications & Usage

Useshelps prevent recurrence of flaking and itching associated with dandruff

Warnings

WarningsFor external use only.

Otc - When Using

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Otc - Stop Use

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 out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • DirectionsWet hair, massage shampoo into scalprinse and repeat if desired.for maximum dandruff control, use at least twice a week or as directed by a doctor

Inactive Ingredient

Inactive ingredients Water, Sodium Laureth Sulfate, Cocamide DEA, Sodium Chloride, Styrene/Acrylates Copolymer, Coco-Glucoside, Polyquaternium-7, Fragrance, Tetrasodium EDTA, Magnesium Nitrate, Methylchloroisothiazolinone, Methylisothiazolinone, Magnesium Chloride, Citric Acid, Shea Butter, Sweet Almond Oil.

* Please review the disclaimer below.

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