PATCHOLOGY BREAKOUT BOX 3-IN-1 ACNE TREATMENT

Manufacturer
Iontera, Inc
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:40:58

Label at a glance#

ProductPATCHOLOGY BREAKOUT BOX 3-IN-1 ACNE TREATMENT
Active ingredientSALICYLIC ACID
Label structure9 sections

Dosage and administration

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 every other day. Sensitivity test for a new user: Apply product to one or two small af...

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 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

INACTIVE INGREDIENT SECTION

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.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-243-0646 24/7, 365

Report serious adverse reactions to: 83 Morse St. Suite 8A Norwood, MA 02062

Company Information

SPL UNCLASSIFIED SECTION

DIST. BY RARE BEAUTY BRANDS, INC.

NORWOOD, MA 02062

DESIGNED IN THE USA

MADE IN KOREA

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

breakout box revbreakout box rev

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1994404salicylic acid 0.5 % Medicated PatchPSN4
1994404salicylic acid 0.005 MG/MG Medicated PatchSCD4
1994404salicylic acid 0.5 % Medicated PatchSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72204-002-012025-07-29C16284748780-13b156c62-2e60-fb37-e063-e6dba90a4e07PATCHOLOGY BREAKOUT BOX 3-IN-1 ACNE TREATMENT KIT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72204-002-01PATCHOLOGY BREAKOUT BOX 3-IN-1 ACNE TREATMENT1 in 1 BOXKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72204-002PATCHOLOGY BREAKOUT BOX 3-IN-1 ACNE TREATMENT (SALICYLIC ACID) KIT [IONTERA, INC]4Legacy NDC, 1 package rows20241208_8a6c911b-5714-0884-e053-2a95a90a5d3c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72204-00272204-002-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2860b736-703b-63d7-e063-6394a90ae7ad8a6c911b-5714-0884-e053-2a95a90a5d3c2024-12-03WarningsExact identifier
spl id: 2860b736-703b-63d7-e063-6394a90ae7ad
spl set id: 8a6c911b-5714-0884-e053-2a95a90a5d3c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.