NDC 66993-945 Benzoyl Peroxide

Benzoyl Peroxide

NDC Product Code 66993-945

NDC 66993-945-12

Package Description: 237 mL in 1 BOTTLE

NDC Product Information

Benzoyl Peroxide with NDC 66993-945 is a a human over the counter drug product labeled by Prasco Laboratories. The generic name of Benzoyl Peroxide is benzoyl peroxide. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Prasco Laboratories

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.

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 60 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.

  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LAURETH-12 (UNII: OAH19558U1)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM COCO-SULFATE (UNII: 3599J29ANH)
  • SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • DISODIUM OLEAMIDO MEA-SULFOSUCCINATE (UNII: 5M1101WGSY)

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: Prasco Laboratories
Labeler Code: 66993
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: 02-28-2019 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’.

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Information for Patients

Benzoyl Peroxide Topical

Benzoyl Peroxide Topical is pronounced as (ben' zoe il)

Why is benzoyl peroxide topical medication prescribed?
Benzoyl peroxide is used to treat mild to moderate acne....
[Read More]

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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

Active Ingredient(S)

Benzoyl Peroxide USP

Purpose

Acne medication

Use(S)

  • For the treatment of acne

For External Use Only.

  • Avoid contact with eyes, eyelids, lips and mucous membranes.

Do Not Use If You

  • Have very sensitive skinare sensitive to benzoyl peroxide

When Using This Product

  • Avoid unnecessary sun exposure and use a sunscreen.Avoid contact with eyes, lips, and mouth.Avoid contact with hair or dyed fabrics, which may be bleached by this product.Skin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling.Irritation may be reduced by using the product less frequently or in a lower concentration.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.

Keep Out Of Reach Of Children

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

Directions

  • SHAKE WELL.Clean the skin thoroughly before applying this product. One to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry. Because 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 doctor. If going outside, apply sunscreen after using this product. Follow directions in the sunscreen labeling.If irritation or sensitivity develops stop use of both products and ask a doctor.

Other Information

Store at controlled room temperature, 15º-30ºC (59º-86ºF)

Inactive Ingredients

Carbomer interpolymer type A NF, cetyl alcohol NF, disodium oleamido MEA-sulfosuccinate, edetate disodium USP, glycerin USP, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate NF, propylene glycol USP, purified water USP, sodium coco-sulfate, sodium lauroamphoacetate, and xanthan gum NF.

Questions?

Call 1-866-525-0688

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