NDC 74690-009 Dr. C. Tuna Acne Pore Purifying Toner

Salicylic Acid

NDC Product Information

Dr. C. Tuna Acne Pore Purifying Toner with NDC 74690-009 is a a human over the counter drug product labeled by Farmasi Us Llc. The generic name of Dr. C. Tuna Acne Pore Purifying Toner is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Farmasi Us Llc

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.

Dr. C. Tuna Acne Pore Purifying Toner 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.

  • SALICYLIC ACID 5 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)
  • ALCOHOL (UNII: 3K9958V90M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SALIX ALBA BARK VOLATILE OIL (UNII: PW3MX00JXN)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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: Farmasi Us Llc
Labeler Code: 74690
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: 01-20-2021 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 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.

Dr. C. Tuna Acne Pore Purifying Toner Product Label Images

Dr. C. Tuna Acne Pore Purifying Toner 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 Ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment

Use

For the treatment of acne.

Warnings

For external use only

When Using This Product

Skin irritation and dryness is more likely to occur if you combine this product with other topical acne skincare products. If irritation occurs, only use one topical acne skincare product at a time. Avoid sun exposure and use a sunscreen. Avoid contact with the eyes, lips and mouth. If contact


occurs, flush thoroughly with water. Skin irritation may occur, characterized by redness or tingling; if increased, discontinue use and seek medical advice.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use

If you have very sensitive skin or are sensitive to salicylic acid.

Directions

After cleansing, apply to face with a soft cotton ball or pad. Avoid the eye area. Do not rinse. Follow with Acne Blemish Control Serum.

Other Information

Store at room temperature.

Inactive Ingredients

Water/Aqua, Alcohol Denat, Propylene Glycol, Polysorbate 20, Glycerin, Butylene Glycol, Hamamelis Virginiana Water, Dehydroacetic Acid, Benzyl Alcohol, Glycolic Acid, Phenoxyethanol, Salix Alba Bark Water, Ethylhexylglycerin.

* Please review the disclaimer below.