NDC 72288-229 Acne Treatment

Benzoyl Peroxide

NDC Product Code 72288-229

NDC Product Information

Acne Treatment with NDC 72288-229 is a a human over the counter drug product labeled by Amazon. The generic name of Acne Treatment is benzoyl peroxide. The product's dosage form is gel and is administered via topical form.

Labeler Name: Amazon

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.

Acne Treatment 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 1 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.

  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • LAURETH-4 (UNII: 6HQ855798J)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • 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.

Product Labeler Information

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

Labeler Name: Amazon
Labeler Code: 72288
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: 03-22-2019 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.

Acne Treatment Product Label Images

Acne Treatment 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 Ingredients

Benzoyl peroxide 10%

Purpose

Acne medication

Use

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 timeavoid unnecessary sun exposure and use a sunscreenavoid contact with eyes, lips and mouthavoid  contact with hair and dyed fabrics, which may be bleached by this productskin irritation may occur, characterized by redness, buring, itching, peeling or posible swelling.  Irritation may be reduced by using the product less frequently or in a lower concentration

Stop Use And Ask A Doctor If

Irritation becomes severe

Keep Out Of Reach Of Children

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

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 daily application to once a day or every other dayif going outside, apply sunscreen after using this product.  If irritation or sensitivity develops stop use of both products and ask a doctor

Inactive Ingredients

Carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

Claims

This acne medication contains maximum strength benzoyl peroxide.  The micronized benzoyl peroxide formula goes to work immediately, releasing the medicine deep into the pore where pimples begin

Adverse Reactions Section

DSTRIBUTED BY:Amazon. com Services, Inc.Seattle, WA 981091-877-485-03852019 Amazon.com Inc. or its afiliates. All rights reserved.Solimo and al related logos are trademarks of Amazon.com, Inc. or its affiliates.29.001/229AC

* Please review the disclaimer below.

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