NDC 73350-105 Vie Naturelle Acne Body

Benzoyl Peroxide

NDC Product Code 73350-105

NDC CODE: 73350-105

Proprietary Name: Vie Naturelle Acne Body 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: Benzoyl Peroxide 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat mild to moderate acne. It may be used in combination with other acne treatments. When applied to the skin, benzoyl peroxide works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

NDC Code Structure

  • 73350 - Tnt Pro Series

NDC 73350-105-08

Package Description: 237 mL in 1 BOTTLE, SPRAY

NDC Product Information

Vie Naturelle Acne Body with NDC 73350-105 is a a human over the counter drug product labeled by Tnt Pro Series. The generic name of Vie Naturelle Acne Body is benzoyl peroxide. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Tnt Pro Series

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Vie Naturelle Acne Body 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.

  • BENZOYL PEROXIDE 25 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)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • WITCH HAZEL (UNII: 101I4J0U34)
  • MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)

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: Tnt Pro Series
Labeler Code: 73350
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: 08-05-2019 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: 12-31-2021 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.

Vie Naturelle Acne Body Product Label Images

Vie Naturelle Acne Body 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 Ingredients:

Benzoyl Peroxide 2.5%

Use For:

For the treatment of acne. Clears up acne pimples and blemishes, and allows skin to heal. Helps prevent new pimples and blemishes from forming.

Warnings:

  • For external use only.Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.Because 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 doctor. If bothersome dryness or peeling occurs, reduce application to once per day.

Do Not Use

For prolonged periods without consulting a doctor.

Keep Out Of Reach Of Children.

If swallowed, contact physician or poison control center immediately. Store at room temperature.

Directions:

Cleanse the skin thoroughly before applying medication. Apply an even layer over affected area. Do not use on broken skin or large parts of the body. *For best results apply one to three times per day.

Other Ingredients:

Aqua (Deionized Water), Ethylhexylglycerin, Eucalyptus Globulus Oil, Hamamelis Virginiana (Witch Hazel) Distillate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate-20, Salicylic Acid.

* Please review the disclaimer below.