NDC 52205-003 Theraspec Acne Cleanser

Benzoyl Peroxide

NDC Product Code 52205-003

NDC Product Information

Theraspec Acne Cleanser with NDC 52205-003 is a a human over the counter drug product labeled by Salient Labs, Llc. The generic name of Theraspec Acne Cleanser is benzoyl peroxide. The product's dosage form is soap and is administered via topical form.

Labeler Name: Salient Labs, Llc

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 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.

Theraspec Acne Cleanser 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 5 g/100mL

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.

  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
  • ALLANTOIN (UNII: 344S277G0Z)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • ISOPENTYLDIOL (UNII: 19NOL5474Q)
  • JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)

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: Salient Labs, Llc
Labeler Code: 52205
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: 04-18-2019 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.

Theraspec Acne Cleanser Product Label Images

Theraspec Acne Cleanser 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

Benzoyl Peroxide 5%

Otc - Purpose

Acne medication

Use

For the treatment of acne

Warnings

For external use only

Otc - Do Not Use

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide

Otc - When Using

  • When using this product keep away from eyes, lips and mouthavoid unnecessary sun exposure and use a sunscreenavoid contact with hair, dyed fabric, including carpet and clothing which may be bleached by this productskin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. lf irritation becomes severe, discontinue use: if irritation still continues, consult a doctor.using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

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. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Dosage & Administration

Directions Wet face. Gently massage all over face for 20-30 seconds, avoiding eye area. Rinse thoroughly and pat dry. Recommended for use twice daily.

Inactive Ingredient

Inactive Ingredients Acrylates Copolymer, Allantoin, Aqua (Deionized Water), Benzyl Alcohol, Ceteareth-20, Dehydroacetic Acid, Hydrolyzed Jojoba Esters, lsopentyldiol, Jojoba Esters, Sodium Cocyl lsethionate.

* Please review the disclaimer below.

Previous Code
52205-001
Next Code
52219-010