NDC 24286-1573 Acne Treatment With Sulfur

Sulfur

NDC Product Code 24286-1573

NDC 24286-1573-1

Package Description: 74 g in 1 TUBE

NDC Product Information

Acne Treatment With Sulfur with NDC 24286-1573 is a a human over the counter drug product labeled by Dlc Laboratories, Inc.. The generic name of Acne Treatment With Sulfur is sulfur. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Dlc Laboratories, Inc.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.

Acne Treatment With Sulfur 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 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.

  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)

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: Dlc Laboratories, Inc.
Labeler Code: 24286
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: 08-16-2019 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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Acne Treatment With Sulfur Product Label Images

Acne Treatment With Sulfur 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

Manufactured by: De La Cruz Products A Division of DLC Laboratories, Inc. | Paramount, CA 90723 USA

Active Ingredient

Sulfur, 5%

Purpose

Acne medication

Uses

  • For the treatment of acnepenetrates the pores and dries and clears acne pimples and blackheadshelps to keep new acne pimples and blackheads from forming

Warnings

For external use only

Do Not Use On

  • Broken skinlarge areas of the skin

When Using This Product

  • Do not get into eyesskin irritation and dryness is more likely to occur if you use another topical acne medication at the same time or right after use of this product. If irritation occurs, only use one topical acne medication at a time.apply only to areas with acne

Otc - Stop Use

Stop use and consult a doctor if excessive skin irritation develops or increases.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Cleanse the skin thoroughly before applyingcover the entire affected area with a thin layerleave on for 10 minutesthoroughly remove with waterbecause excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctorif bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive Ingredient

Polyethylene glycol

Questions

1-800-858-3889

* Please review the disclaimer below.