NDC 73324-091 Aloe Coal 01

Pyrithione Zinc

NDC Product Code 73324-091

NDC 73324-091-08

Package Description: 237 mL in 1 BOTTLE

NDC Product Information

Aloe Coal 01 with NDC 73324-091 is a a human over the counter drug product labeled by T. Spruill, Llc. The generic name of Aloe Coal 01 is pyrithione zinc. The product's dosage form is liquid and is administered via topical form.

Labeler Name: T. Spruill, Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Aloe Coal 01 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 10 mg/mL

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • OAT (UNII: Z6J799EAJK)
  • BIOTIN (UNII: 6SO6U10H04)
  • GRAPEFRUIT (UNII: O82C39RR8C)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
  • JOJOBA OIL (UNII: 724GKU717M)
  • SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)

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: T. Spruill, Llc
Labeler Code: 73324
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: 08-26-2019 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.

Aloe Coal 01 Product Label Images

Aloe Coal 01 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 1.00%

Purpose

Dandruff Treatment

Uses:

For relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent chance of recurrence.

Warnings

For external use only.

When Using This Product

Avoid contact with eyes. If this happens, rinse thoroughly with water.

Stop And Ask A Doctor

If condition worsens or does not improve after using this product as directed.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Apply shampoo to wet hair by massaging into lather with pads of finger tips. Rinse thoroughly. For best results, let shampoo sit for 3-5 minutes before rinsing thoroughly. Use a least twice per week, or as directed by physician.

Other Ingredients:

Activated Charcoal Powder, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Avena Sativa (Oat) Protein, Biotin, Citrus Grandis (Grapefruit) Oil, Cocamidopropyl Betaine, Dimethicone, Equisetum Arvense (Horsetail) Extract, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Hydrolyzed Rice Protein, Olea Europaea (Olive) Oil, Lauryl Glucoside, di-Panthenol, Phenoxyethanol, Rosa Canina (Rose Hips) Oil, Simmondsia Chinensis (Jojoba) Oil, Sodium C14-16 Alpha Olefin Sulfonate, Sodium Cocoyl Isethionate, Sodium Lauryl Glucose Carboxylate

* Please review the disclaimer below.