NDC 73098-001 Lemaitre Sulfur Acne Treatment

Sulfur

NDC Product Code 73098-001

NDC Code: 73098-001

Proprietary Name: Lemaitre Sulfur Acne Treatment 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

  • 73098 - Lemaitre Perfumeria Y Jabones Sas
    • 73098-001 - Lemaitre Sulfur

NDC 73098-001-01

Package Description: 1 CELLO PACK in 1 BOX > 100 g in 1 CELLO PACK

NDC Product Information

Lemaitre Sulfur Acne Treatment with NDC 73098-001 is a a human over the counter drug product labeled by Lemaitre Perfumeria Y Jabones Sas. The generic name of Lemaitre Sulfur Acne Treatment is sulfur. The product's dosage form is soap and is administered via topical form.

Labeler Name: Lemaitre Perfumeria Y Jabones Sas

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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.

Lemaitre Sulfur Acne 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 9 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.

  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CARAMEL (UNII: T9D99G2B1R)
  • SODIUM PALMATE (UNII: S0A6004K3Z)
  • SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ETIDRONIC ACID (UNII: M2F465ROXU)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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: Lemaitre Perfumeria Y Jabones Sas
Labeler Code: 73098
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: 05-13-2019 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.

Lemaitre Sulfur Acne Treatment Product Label Images

Lemaitre Sulfur Acne 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

Made in ColombiaDistributed by: Lemaitre Perfumeria y Jabones S.A.SBosque, Transversal 48 #21-113Cartagena de Indias, ColombiaPhone: (202) 3706943www.perfumerialemaitre.com

Otc - Active Ingredient

Active ingredientSulfur 9%

Otc - Purpose

PurposeAcne treatment

Indications & Usage

  • Usesfor the treatment of acnedries and clears acne blemishes, acne pimples, blackheads and whiteheadshelps prevent new acne blemishes, acne pimples, blackheads and whiteheads from forming

Warnings

WarningsFor external use only

Otc - Do Not Use

  • Do not use on
  • Broken skinlarge areas of the skin

Otc - When Using

  • When using this productavoid contact with the eyesapply only to areas with acneskin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne medication at a time.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • Directionsclean the skin thoroughly before applying this productcover the entire affected area with a thin layer one to three times daily. Rinse thoroughlybecause excessive dryness 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 Ingredient

Inactive ingredientssodium palmate, sodium palm kernelate, water, glycerin, sodium chloride, fragrance, etidronic acid, tetrasodium EDTA, BHT, titanium dioxide, FD&C yellow 5. May contain caramel.

* Please review the disclaimer below.

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