NDC 72704-129 Clarifying Spot With Sulfur Plus Green Clay Acne Medication

Sulfur

NDC Product Code 72704-129

NDC CODE: 72704-129

Proprietary Name: Clarifying Spot With Sulfur Plus Green Clay Acne Medication What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Sulfur What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 72704 - Lancer Skincare Llc.
    • 72704-129 - Clarifying Spot With Sulfur Plus Green Clay

NDC 72704-129-01

Package Description: 1 TUBE in 1 CARTON > 9 mL in 1 TUBE

NDC Product Information

Clarifying Spot With Sulfur Plus Green Clay Acne Medication with NDC 72704-129 is a a human over the counter drug product labeled by Lancer Skincare Llc.. The generic name of Clarifying Spot With Sulfur Plus Green Clay Acne Medication is sulfur. The product's dosage form is solution and is administered via topical form.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Clarifying Spot With Sulfur Plus Green Clay Acne Medication 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.


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.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • AZELAIC ACID (UNII: F2VW3D43YT)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • PAPAIN (UNII: A236A06Y32)
  • BROMELAINS (UNII: U182GP2CF3)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • DISODIUM CARBOXYETHYL SILICONATE (UNII: 4U4C79679G)
  • LEDIKITE (UNII: D7BC5B0F46)
  • MONTMORILLONITE (UNII: A585MN1H2L)
  • KAOLIN (UNII: 24H4NWX5CO)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CHROMIC OXIDE (UNII: X5Z09SU859)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Lancer Skincare Llc.
Labeler Code: 72704
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: 10-15-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Clarifying Spot With Sulfur Plus Green Clay Acne Medication Product Label Images

Clarifying Spot With Sulfur Plus Green Clay Acne Medication 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

Other

Drug Facts

Flammable, keep away from fire or flame.

Dist. byLANCER SKINCARE LLC440 N. Rodeo Dr., 3FBeverly Hills, CA 90210

Active Ingredient

Sulfur 10.0%

Purpose

Acne Treatment

Uses

For the management of acne

Warnings

For external use only

Do Not Use On

  • Broken skinLarge areas of the skin

When Using This Product

  • Skin 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 timeapply only to areas with acne

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

Directions

  • Clean the skin thoroughly before applying this productcover the entire affected area with a thin layer one to three times dailybecause excessive drying of the skin may occur, start with one application daily, then gradually increase to two or 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 Ingredients

Alcohol Denat., Water, Azelaic Acid, PVP, Camellia Sinensis Leaf Extract, Salicylic Acid, Papain, Bromelain, Maltodextrin, Glycerin, Magnesium Aluminum Silicate, Disodium Carboxyethyl Siliconate, Illite, Montmorillonite, Kaolin, Calcite, Sodium Hydroxide, Chromium Oxide Greens, Titanium Dioxide

Questions?

1800-899-0744 M-F 9-5PST

* Please review the disclaimer below.