NDC 72841-201 Treeactiv Cystic Acne Spot Treatment

Sulfur

NDC Product Code 72841-201

NDC 72841-201-01

Package Description: 1 JAR in 1 BOX > 15 mL in 1 JAR

NDC Product Information

Treeactiv Cystic Acne Spot Treatment with NDC 72841-201 is a a human over the counter drug product labeled by Leiluna Llc. The generic name of Treeactiv Cystic Acne Spot Treatment is sulfur. The product's dosage form is paste and is administered via topical form.

Labeler Name: Leiluna Llc

Dosage Form: Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty 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.

Treeactiv Cystic Acne Spot Treatment 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 30 mg/mL

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)
  • HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
  • BENTONITE (UNII: A3N5ZCN45C)
  • ALCOHOL (UNII: 3K9958V90M)
  • LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
  • ACACIA (UNII: 5C5403N26O)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • LEMON OIL (UNII: I9GRO824LL)
  • MENTHA PIPERITA LEAF (UNII: A389O33LX6)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • SODIUM GLUCONATE (UNII: R6Q3791S76)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MENTHA SPICATA OIL (UNII: C3M81465G5)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • ALLANTOIN (UNII: 344S277G0Z)
  • GRAPEFRUIT OIL (UNII: YR377U58W9)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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.
  • 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: Leiluna Llc
Labeler Code: 72841
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: 05-07-2020 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: 12-31-2021 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.

Treeactiv Cystic Acne Spot Treatment Product Label Images

Treeactiv Cystic Acne Spot Treatment 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

Active Ingredients

Sulfur 3.0%

Otc - Purpose

Acne Treatment

Use

For the treatment of acne.

Warnings

For external use only. 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 time. Do not get into eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor. Apply to affected areas only. Do not use on broken skin or apply to large areas of the body.

Keep Out Of Reach Of Children

If 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

Aqua (Water), Hamamelis Virginiana (Witch Hazel) Water, Bentonite, Alcohol, Leuconostoc/Radish Root Ferment Filtrate, Acacia Senegal Gum, Caprylyl Glycol, Mentha Piperita (Peppermint) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citrus Limon (Lemon) Peel Oil, Alcohol Denat., Mentha Piperita (Peppermint) Leaf ExtractDenotes Organic Ingredient, Sodium Gluconate, Bisabolol (L-alpha), Dimethicone, Mentha Viridis (Spearmint) Leaf Oil, Citric Acid, Eucalyptus Globulus Leaf Oil, Allantoin, Citrus Paradisi (Pink Grapefruit) Peel Oil, Aloe Barbadensis Leaf Juice Powder

Questions?

888-201-6444 | CustomerCare@treeactiv.com

* Please review the disclaimer below.