NDC 72204-002 Patchology Breakout Box 3-in-1 Acne Treatment

Salicylic Acid

NDC Product Code 72204-002

NDC 72204-002-01

Package Description: 1 KIT in 1 BOX * 3 STRIP in 1 PACKET * 24 PATCH in 1 PACKET > .5 g in 1 PATCH * 24 PATCH in 1 PACKET

NDC Product Information

Patchology Breakout Box 3-in-1 Acne Treatment with NDC 72204-002 is a a human over the counter drug product labeled by Iontera, Inc. The generic name of Patchology Breakout Box 3-in-1 Acne Treatment is salicylic acid. The product's dosage form is kit and is administered via form.

Labeler Name: Iontera, Inc

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POVIDONE (UNII: FZ989GH94E)
  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • ALCOHOL (UNII: 3K9958V90M)
  • EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • VITIS VINIFERA SEED (UNII: C34U15ICXA)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • WATER (UNII: 059QF0KO0R)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • BISULFITE ION (UNII: OJ9787WBLU)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Iontera, Inc
Labeler Code: 72204
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: 06-03-2019 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.

Patchology Breakout Box 3-in-1 Acne Treatment Product Label Images

Patchology Breakout Box 3-in-1 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

Active Ingredient(S)

Salicylic Acid 0.5%

Purpose

Acne Treatment

Use

For the treatment of acne

Warnings

For external use only

Otc - When Using

When using this product skin irritation and dryness is likely to occur if you use another topical acne product at the same time. If irritation occurs, only one medication should be used.

Otc - Do Not Use

Do not use if you are allergic to the dressing or to any of the components.

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.

Directions

  • Cleanse thoroughly before applying medication.Apply the sticker on the affected areas. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor. If bothersome dyrness or peeling occurs, reduce application to once a day or even every other day.Sensitivity test for a new user: Apply product to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Inactive Ingredients

Acrylates Copolymer, Vinyl Caprolactam/VP/Dimethylaminoethyl Methacrylate Copolymer, Water (Aqua/Eau), Alcohol Denat., Melaleuca Alternifolia (Tea Tree) Leaf Oil, Epilobium Angustifolium Flower/Leaf/Stem Extract, Volcanic Ash, Sodium Hyaluronate, Vitis Vinifera (Grape) Seed Extract, Sodium Metabisulfite, Butylene Glycol, Phytosphingosine, Phenoxyethanol, Polysorbate 80, PVP.

Company Information

DIST. BY RARE BEAUTY BRANDS, INC.NORWOOD, MA 02062DESIGNED IN THE USAMADE IN KOREA

Product Packaging

PATCHOLOGYpure pore perfectionBREAKOUT BOX

3-IN-1 ACNE TREATMENT KIT
24 BLEMISH SHRINKING SALICYLIC ACID DOTS

24 WHITEHEAD ABSORBING HYDROCOLLOID DOTS

3 DETOXIFYING CHARCOAL NOSE STRIPS

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