NDC 71566-100 Happy Cappy

Pyrithione Zinc

NDC Product Code 71566-100

NDC 71566-100-08

Package Description: 237 mL in 1 BOTTLE, PLASTIC

NDC 71566-100-11

Package Description: 15 mL in 1 PACKET

NDC Product Information

Happy Cappy with NDC 71566-100 is a a human over the counter drug product labeled by Pediatric Solutions, Llc. The generic name of Happy Cappy is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1091088 and 1991486.

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.

Happy Cappy 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)
  • COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
  • ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)
  • APPLE (UNII: B423VGH5S9)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: Pediatric Solutions, Llc
Labeler Code: 71566
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: 12-07-2017 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.

Happy Cappy 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

Active Ingredient

Pyrithione Zinc 0.95%

Purpose

Seborrheic Dermatitis and Dandruff

Uses

Helps eliminate scalp and skin scaling, redness, flaking, itching, and irritation associated with dandruff and seborrheic dermatitis.

Warnings

For external use only.

Otc - Ask Doctor

Ask a doctor before use if you have • seborrheic dermatitis covering a large area of the body.

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 call a Poison Control Center right away.

Directions •

  • For best results use at least twice a week or as directed by a doctor.
  • Wet hair thoroughly, massage on to scalp and skin, rinse.

Inactive Ingredients

Water (Aqua), Glycerin, Sodium Lauroyl Methyl Isethionate, Sodium Laurylglucosides Hydroxypropylsulfonate, Cocamidopropyl Hydroxysultaine, Acrylates Copolymer, Pyrus Malus (Apple) Fruit Extract, Phenoxyethanol, Sodium Chloride, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Dipotassium Glycyrrhizate, Panthenol, Ethylhexylglycerin, Citric Acid.

* Please review the disclaimer below.