NDC 72811-137 111 Medco Benzoyl Peroxide

Benzoyl Peroxide

NDC Product Code 72811-137

NDC Product Information

111 Medco Benzoyl Peroxide with NDC 72811-137 is a a human over the counter drug product labeled by 111 Medco. The generic name of 111 Medco Benzoyl Peroxide is benzoyl peroxide. The product's dosage form is soap and is administered via topical form.

Labeler Name: 111 Medco

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


111 Medco Benzoyl Peroxide Active Ingredient(s)

Additional informationCallout TooltipWhat 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 100 mg/g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)
  • COCONUT ACID (UNII: 40U37V505D)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM ISETHIONATE (UNII: 3R36J71C17)
  • ETHYLENE-VINYL ACETATE COPOLYMER (15% VINYL ACETATE) (UNII: V9BQI51YUL)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SODIUM COCOATE (UNII: R1TQH25F4I)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • EDETATE SODIUM (UNII: MP1J8420LU)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: 111 Medco
Labeler Code: 72811
FDA Application Number: part333D Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 04-02-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

111 Medco Benzoyl Peroxide Product Label Images

111 Medco 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

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Drug Facts

​MADE IN CANADA
Distributed by:111MedCo, LLC8 The Green, Suite 5287Dover, DE 199011-888-711-7090

Otc - Active Ingredient

Active ingredientBenzoyl peroxide 10%

Otc - Purpose

PurposeAcne medication

Indications & Usage

Use for the treatment of acne; helps prevent new acne blemishes from forming

Warnings

WarningsFor external use only

Otc - Do Not Use

  • Do not useif you have very sensitive skinif you are sensitive to benzoyl peroxide

Otc - When Using

  • When using this productskin 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 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 reduced by using the product less frequently or in a lower concentration.

Otc - Stop Use

  • Stop use and consult a doctor if irritation becomes severe.

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.

Dosage & Administration

  • Directionsusing warm water, wash the affected area for 1 to 2 minutesrinse well and pat dry with a clean towelbecause too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctorif bothersome dryness or peeling occurs, reduce application to once a day or every other dayif going outside, apply sunscreen after using the productIf irritation or sensitivity develops, stop use of both products and ask a doctor.

Storage And Handling

Other information Store at controlled room temperature 59° - 86°F (15° - 30°C)

Inactive Ingredient

Inactive ingredients sodium cocoyl isethionate, stearic acid, coconut acid, water, sodium isethionate, ethylene/VA copolymer, zea mays (corn) starch, sodium tallowate, titanium dioxide, mineral oil, cocamidopropyl betaine, tetrasodium etidronate, sodium cocoate, glycerin, sodium chloride, tetrasodium EDTA

* Please review the disclaimer below.

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