NDC 73528-100 Balancing

Zinc Pyrithione

NDC Product Code 73528-100

NDC 73528-100-01

Package Description: 280 mL in 1 BOTTLE, DISPENSING

NDC 73528-100-02

Package Description: 85 mL in 1 BOTTLE, DISPENSING

NDC 73528-100-03

Package Description: 9 mL in 1 PACKET

NDC Product Information

Balancing with NDC 73528-100 is a a human over the counter drug product labeled by No Flakes Given, Llc.. The generic name of Balancing is zinc pyrithione. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: No Flakes Given, Llc.

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.

Balancing 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)

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.
  • 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: No Flakes Given, Llc.
Labeler Code: 73528
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: 02-01-2020 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 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.

Balancing 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

Zinc Pyrithione 1.0%

Purpose

Anti-Dandruff

Warnings

For external use only. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
If condition worsens or does not improve after regular use of this product as directed, conult a doctor.
Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.
Do not use on children under 2 years of age, unless directed by a doctor.

Uses

For the relief of symptoms from scalp itch, irritation, flaking and redness associated with dandruff.

Directions

Apply to wet hair and scalp. Massage to lather and let sit for 2-3 minutes. Rinse thoroughly. Repeat if desired.For best results, use at least twice a week or as directed by a doctor.For maximum dandruff control, use every time you shampoo.

Questions

1-877-No-Flake (1-877-663-5253)

Inactive Ingredients

Water (Aqua), Sodium Cocoyl Isethionate, Sodium Lauroamphoacetate, Acrylates Copolymer, Ethylhexyl Olivate, Stearyl Alcohol, Carthamus Tinctorius (Safflower) Seed Oil, Allium Sativum (Garlic) Bulb Extract, Pyrus Malus (Apple) Fruit Extract, Camellia Sinensis Leaf Extract, Panthenol, Citrus Reticulata (Tangerine) Peel Oil, Foeniculum Vulgare (Fennel) Oil, Lavandula Angustifolia (Lavender) Oil, Mentha Aquatica Leaf Oil, Bertholletia Excelsa Seed Oil, Mentha Arvensis (Cornmint) Leaf Oil, Orbignya Oleifera Seed Oil, Copaifera Officinalis (Balsam Copaiba) Resin, Rosmarinus Officinalis (Rosemary) Leaf Oil, Salvia Sclarea (Clary) Oil, Vanillin, Cocos Nucifera (Coconut) Oil, Laminaria Saccharina Extract, Squalane, Caprylyl Glycol, Trimethylsiloxyamodimethicone, C11-15 Pareth-7, C12-16 Pareth-9, Trideceth-12, Yeast Ferment Extract, Decylene Glycol, Guar Hydroxypropyltrimonium Chloride, PEG-12 Dimethicone, Glycerin, Sodium Isethionate, Lactobacillus Ferment, Octenidine HCL, Sodium Polynaphthalenesulfonate, Xanthan Gum, Hexamidine Diisethionate, Ethylhexylglycerin

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

* Please review the disclaimer below.