NDC 59958-406 Slmd Bp Body Wash

Benzoyl Peroxide

NDC Product Code 59958-406

NDC 59958-406-02

Package Description: 1 TUBE in 1 CARTON > 222 g in 1 TUBE (59958-406-01)

NDC Product Information

Slmd Bp Body Wash with NDC 59958-406 is a a human over the counter drug product labeled by Owen Biosciences Inc.. The generic name of Slmd Bp Body Wash is benzoyl peroxide. The product's dosage form is gel and is administered via topical form.

Labeler Name: Owen Biosciences Inc.

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.

Slmd Bp Body Wash 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/100g

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)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • COCO-BETAINE (UNII: 03DH2IZ3FY)

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: Owen Biosciences Inc.
Labeler Code: 59958
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: 08-30-2019 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.

Slmd Bp Body Wash Product Label Images

Slmd Bp Body Wash 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 5.0%

Use

For the management of acne.

Warningsfor External Use Only.

When using this product:• skin irritation and dryness is more likely tooccur if you use another topical acnemedication at the same time. If irritationoccurs, only use one topical acne medicationat a time.• avoid unnecessary sun exposure and use asunscreen• avoid contact with the eyes, lips, and mouth• avoid contact with hair and dyed fabrics,which may be bleached by this products• skin irritation may occur, characterized byredness, burning, itching, peeling, or possiblyswelling. Irritation may be reduced by usingthe product less frequently or in a lowerconcentration

Do Not Use If You

• have sensitive skin• are sensitive to benzoyl peroxide

Stop Use And Ask A Doctor If

•irriatation becomes servere

Keep Out Of Reach Of Children.

If swallowed, get medical help orcontact a Poison Control Centerright away

Directions

• Lather between palms with water. Massagein circular motion on wet skin for 20-30seconds and rinse thoroughly.• Because excessive drying of the skin mayoccur, start with one application daily. Thengradually increase to two or three times dailyif needed or as directed by a doctor.• if bothersome dryness or peeling occurs,reduce application to once a day or everyother day.• if going outside, apply sunscreen after usingthis product. If irritation or sensitivitydevelops, stop use of both products and aska doctor.• Sensitivity Test for a New User: Applyproduct sparingly to one or two smallaffected areas during the first 3 days. If nodiscomfort occurs, follow the directionsstated above.

Bp Body Wash.Jpg

BP Body Wash.jpg

* Please review the disclaimer below.