NDC 59958-407 Slmd Silver Sulfur Acne Cream

Sulfur

NDC Product Code 59958-407

NDC 59958-407-02

Package Description: 1 BOTTLE in 1 CARTON > 50 g in 1 BOTTLE (59958-407-01)

NDC Product Information

Slmd Silver Sulfur Acne Cream with NDC 59958-407 is a a human over the counter drug product labeled by Owen Biosciences Inc.. The generic name of Slmd Silver Sulfur Acne Cream is sulfur. The product's dosage form is cream and is administered via topical form.

Labeler Name: Owen Biosciences Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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 Silver Sulfur Acne Cream 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.

  • SULFUR 3 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)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ALMOND OIL (UNII: 66YXD4DKO9)

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 Silver Sulfur Acne Cream Product Label Images

Slmd Silver Sulfur Acne Cream 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

Sulfur 3.0%

Purpose

Acne Treatment

Use

Use for the management of acne

Warningsfor External Use Only.

When using this product:• skin irritation and dryness ismore likely to occur if you useanother topical acne medicationat the same time. If irritationoccurs, only use one topicalacne medication at a time.•apply only to areas with acne• avoid contact with the eyes, lips, and mouthDo not use on:• broken skin• large areas of the skinStop use and ask a doctor ifirriatation becomes servere.Keep out of reach of children.If swallowed, get medical help orcontact a Poison Control Centerright away

Directions

• clean the skin thoroughly beforeapplying this product• cover the entire affected area witha thin layer one to three timesdaily • because excessive dryingof the skin may occur, start withone applicagtion daily, thengradually increase to two or threetimes daily if needed or asdirected by a doctor• if bothersome dryness or peelingoccurs, reduce application toonce a day or every other day• Sensitivity Test for a New User:Apply product sparingly to one ortwo small affected areas duringthe first 3 days. If no discomfortoccurs, follow the directionsstated above.

Keep Out Of Reach Of Children.

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

Sulfur Carton.Jpg

Sulfur Carton.jpg

* Please review the disclaimer below.