NDC 57934-5011 Every Man Jack 2-in-1 Anti-dandruff

Pyrithione Zinc

NDC Product Code 57934-5011

NDC 57934-5011-3

Package Description: 400 mL in 1 BOTTLE

NDC Product Information

Every Man Jack 2-in-1 Anti-dandruff with NDC 57934-5011 is a a human over the counter drug product labeled by Every Man Jack. The generic name of Every Man Jack 2-in-1 Anti-dandruff is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Every Man Jack

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.

Every Man Jack 2-in-1 Anti-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.

  • 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.

  • WATER (UNII: 059QF0KO0R)
  • AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
  • SODIUM COCO-SULFATE (UNII: 3599J29ANH)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • QUATERNIUM-82 (UNII: AFS70NB1WJ)
  • GLYCOL STEARATE (UNII: 0324G66D0E)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • PEG-30 CASTOR OIL (UNII: GF873K38RZ)
  • GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
  • CITRUS MAXIMA SEED (UNII: 083X55C543)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CARAMEL (UNII: T9D99G2B1R)
  • COUMARIN (UNII: A4VZ22K1WT)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
  • MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
  • SPEARMINT OIL (UNII: C3M81465G5)

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: Every Man Jack
Labeler Code: 57934
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: 06-16-2019 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.

Every Man Jack 2-in-1 Anti-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

Active Ingredient

PYRITHIONE ZINC  1%

Purpose

ANTI DANDRUFF

Use

  • FOR RELIEF OF FLAKING AND ITCHING DUE TO DANDRUFF AND SEBORRHEIC DERMATITIS , AND TO HELP PREVENT THEIR RECURRENCE.

Warnings

  • FOR EXTERNAL USE ONLY.ASK A DOCTOR BEFORE USE IF YOU HAVEABORRHEIC DERMATITIS IN AREAS OTHER THAN SCALP.WHEN USING THIS PRODUCTAVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.STOP USE AND ASK A DOCTOR IFCONDITION 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 CHILDRN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Directions

  • SHAMPOO, THEN RINSE THOROUGHLY.FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR ASDIRECTED BY A DOCTOR.

Inactive Ingredients

WATER/AQUA/EAU, AMMONIUM LAURYL SULFATE, SODIUM COCO-SULFATE, DECYL GLUCOSIDE, COCAMIDOPROPYL BETAINE, GLYCERIN, QUATERNIUM 80, GLYCOL STEARATE, DIMETHICONE COPOLYOL, CETRIMONIUM CHLORIDE, PEG-30 CASTOR OIL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, TOCOPHERYL ACETATE (VITAMIN E), HYDROLYZED WHEAT PROTEIN,CITRUS GRANDIS (GRAPEFRUIT) SEED EXTRACT, PANTHENOL (VITAMIN B5), CITRIC ACID, BENZYL ALCOHOL, CARAMEL, COUMARIN, LINALOOL, EUCALYPTUS GLOBULUS (EUCALYPTUS) OIL, MENTHA ARVENSIS (CORNMINT) OIL, MENTHA VIRDIS (SPEARMINT) LEAF OIL, FRAGRANCE/PARFUM.

* Please review the disclaimer below.