NDC 73246-001 Touch Acne Treatment Benzoyl Peroxide

Benzoyl Peroxide

NDC Product Code 73246-001

NDC Code: 73246-001

Proprietary Name: Touch Acne Treatment Benzoyl Peroxide 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: Benzoyl Peroxide 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

  • 73246 - Touch Skin Care, Llc
    • 73246-001 - Touch Acne Treatment

NDC 73246-001-01

Package Description: 227 g in 1 TUBE

NDC Product Information

Touch Acne Treatment Benzoyl Peroxide with NDC 73246-001 is a a human over the counter drug product labeled by Touch Skin Care, Llc. The generic name of Touch Acne Treatment Benzoyl Peroxide is benzoyl peroxide. The product's dosage form is gel and is administered via topical form.

Labeler Name: Touch Skin Care, Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Touch Acne Treatment Benzoyl Peroxide 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.

  • BENZOYL PEROXIDE 25 mg/g

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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SACCHARIDE ISOMERATE (UNII: W8K377W98I)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)

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: Touch Skin Care, Llc
Labeler Code: 73246
FDA Application Number: part333D 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: 07-26-2019 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.

Touch Acne Treatment Benzoyl Peroxide Product Label Images

Touch Acne Treatment Benzoyl Peroxide 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

Distributed by Touch Skin Care, LLC New York, NY 10003

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment Gel

Uses

  • For the treatment of acne

Warnings

  • For external use only

Do Not Use If You

  • Have very sensitive skinAre sensitive to benzoyl peroxide

When Using This Product

  • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.Avoid unnecessary sun exposure and use a sunscreenAvoid contact with the eyes, lips, and mouthAvoid contact with hair and dyed fabrics, which may be bleached by this productSkin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be erduced by using the product less frequently or in a lower concentartion.If going outside, apply sunscreen after using this product.If sensitivity develops or irritation becomes severe, stop use and ask a doctor

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of childrenIf swallowed get medical help or call a poison control center immediatelyKeep away from excessive heat or heat sources

Directions

  • Clean the skin thoroughly before applying this productCover the entire affected area with a thin layer one to three times dailyBecause excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctorIf bothersome dryness or peeling occurs, reduce application to once a day or every other day.Other sun protection measures include limiting sun exposure and wearing protective clothing.

Other Ingredients

Carbomer, Edetate Disodium, Glycerine, Propylene Glycol, Saccharide Isomerate, Sodium Hydroxide, Water.

Other Information

Store at 15 - 25°C (59 - 77°F) Protect from heat. Keep container tightly closed.

* Please review the disclaimer below.

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