NDC 72296-040 Tula Skincare Go Away Acne Spot Treatment

Tula Skincare Go Away Acne Spot Treatment

NDC Product Code 72296-040

NDC CODE: 72296-040

Proprietary Name: Tula Skincare Go Away Acne Spot 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: Tula Skincare Go Away Acne Spot Treatment 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

  • 72296 - Tula Life Llc
    • 72296-040 - Tula Skincare Go Away Acne Spot Treatment

NDC 72296-040-15

Package Description: 1 TUBE in 1 CARTON > 15 g in 1 TUBE

NDC Product Information

Tula Skincare Go Away Acne Spot Treatment with NDC 72296-040 is a a human over the counter drug product labeled by Tula Life Llc. The generic name of Tula Skincare Go Away Acne Spot Treatment is tula skincare go away acne spot treatment. The product's dosage form is liquid and is administered via topical form.

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.

Tula Skincare Go Away 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.


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)
  • DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • LACTOCOCCUS LACTIS (UNII: F1A0PSN10V)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • AZELAIC ACID (UNII: F2VW3D43YT)
  • MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
  • CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • VACCINIUM ANGUSTIFOLIUM LEAF (UNII: B4L873GNG1)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)
  • CITRIC ACID ACETATE (UNII: DSO12WL7AU)
  • BISABOLOL OXIDE A (UNII: 16AE65F94Y)
  • MORINDA CITRIFOLIA FRUIT (UNII: 7829X3G2X5)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • PEG-40 STEARATE (UNII: ECU18C66Q7)
  • POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)

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: Tula Life Llc
Labeler Code: 72296
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: 12-24-2021 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".

* Please review the disclaimer below.

Tula Skincare Go Away Acne Spot Treatment Product Label Images

Tula Skincare Go Away 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

Active Ingredients

Benzoyl Peroxide 5.0%

Purpose

Acne Treatment

Uses

• treats acne• Helps prevent the development or new acne blemishes

Warnings

For external use only


Using other topical medications at the same time or


immediately following use of this product may increase


dryness or irritation of the skin. If this occurs, only one


medication should be used unless directed by a doctor.


When using this product


• avoid contact with the eyes


• if contact occurs, rinse thoroughly with water

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.

Directions

• clean the skin thoroughly before applying this product


• cover the entire affected area with a thin layer one to three


times daily


• 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 a day or every other day

Inactive Ingredients

Aqua/Water/Eau, Benzoyl Peroxide, Dimethyl Isosorbide, Glycerin, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Propanediol, Butylene Glycol, Niacinamide, Lactococcus Ferment Lysate, Lactic Acid, Azelaic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Capryloyl Salicylic Acid, Aloe Barbadensis Leaf Juice, Vaccinium Angustifolium (Blueberry) Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Zingiber Officinale (Ginger) Root Extract, Citric Acid, Bisabolol, Morinda Citrifolia Extract, Xanthan Gum, Trisodium Ethylenediamine Disuccinate, Tocopherol, 1,2-Hexanediol, Caprylyl Glycol, Carbomer, Silica, Sodium Citrate, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Ethylhexylglycerin, Hydroxyacetophenone, Isohexadecane, PEG-40 Stearate, Polyglyceryl-2 Isostearate, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Sodium Chloride, Sodium Hydroxide, Sorbitan Stearate, Phenoxyethanol

* Please review the disclaimer below.