NDC 42851-187 Zo Skin Health Post Procedure Program

Aluminum Acetate

NDC Product Code 42851-187

NDC Code: 42851-187

Proprietary Name: Zo Skin Health Post Procedure Program What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Aluminum Acetate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 42851 - Zo Skin Health, Inc.
    • 42851-187 - Zo Skin Health Post Procedure Program

NDC 42851-187-06

Package Description: 1 KIT in 1 CARTON * 60 mL in 1 TUBE * 47 mL in 1 TUBE * 6 g in 1 PACKET (42851-090-06) * 113 g in 1 TUBE * 50 mL in 1 TUBE

NDC Product Information

Zo Skin Health Post Procedure Program with NDC 42851-187 is a a human over the counter drug product labeled by Zo Skin Health, Inc.. The generic name of Zo Skin Health Post Procedure Program is aluminum acetate. The product's dosage form is kit and is administered via form.

Labeler Name: Zo Skin Health, Inc.

Dosage Form: Kit - A packaged collection of related material.

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.

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)
  • OAT (UNII: Z6J799EAJK)
  • SOYBEAN (UNII: L7HT8F1ZOD)
  • WHEY (UNII: 8617Z5FMF6)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Zo Skin Health, Inc.
Labeler Code: 42851
FDA Application Number: part347 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: 07-02-2019 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.

Zo Skin Health Post Procedure Program Product Label Images

Zo Skin Health Post Procedure Program 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

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

Otc - Purpose

Active IngredientsPurposeAluminum Sulfate Tetradecahydrate, 2850 mgAstringentWhen combined together in water, these ingredients form the active ingredient aluminum acetate. See DirectionsCalcium Acetate Monohydrate, 2016 mgAstringent

Uses

  • For temporary relief of minor skin irritations due to rashes caused by soaps, detergents, cosmetics, or jewelry.

Warnings

For external use only.

When Using This Product

  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.do not cover compress or wet dressing with plastic to prevent evaporationin some skin conditions, soaking too long may overdry

Stop Use And Ask A Doctor If

  • Condition worsens or symptoms persist for more than 7 days

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.

Directions

  • Dissolve 1 packet in 12 oz. of cool or warm water.stir until fully dissolved; do not strain or filter.The resulting mixture contains 0.45% aluminum acetate and is ready for use.For use as a compress or wet dressing:soak a clean, soft cloth in the solutionapply cloth loosely to affected area for 15 to 30 minutesrepeat as needed or as directed by a doctordiscard solution after each use

Other Information

  • Protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Dextrin, Avena Sativa (Oat) Kernel Protein, Glycine Soja (Soybean) Protein, Whey Protein, Potassium Sorbate, Chitosan.

* Please review the disclaimer below.

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