Spot On Acne Patch

Manufacturer
ACNEFREE, LLC | Kovas Co., Ltd
Effective date
2024-06-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:13:51

Label at a glance#

ProductSpot On Acne Patch
Active ingredientSALICYLIC ACID
Label structure6 sections

Dosage and administration

Cleanse and thoroughly dry your face. Remove patch adn apply directly onto the blemish. Leave patch on for at least 6 hours. Best used within 10 days after opening.

Label contents#

Full prescribing information#

USE

INDICATIONS & USAGE SECTION

for treatment of acne

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use if you are allergic to the patch or any of its components

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation occurs.

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse and thoroughly dry your face. Remove patch adn apply directly onto the blemish. Leave patch on for at least 6 hours. Best used within 10 days after opening.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Spot on Acne Patch labelSpot on Acne Patch label

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Spot On Acne Patch labelSpot On Acne Patch label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1994404salicylic acid 0.5 % Medicated PatchPSN2
1994404salicylic acid 0.005 MG/MG Medicated PatchSCD2
1994404salicylic acid 0.5 % Medicated PatchSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80861-111-012025-07-29C16284748780-13b156c62-2bfd-fb37-e063-e6dba90a4e07f8fe4fff-e83f-36b8-e053-6394a90aa932

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80861-111-01Spot On Acne Patch36 in 1 CARTONPATCH362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80861-111SPOT ON ACNE PATCH (SALICYLIC ACID) PATCH [ACNEFREE, LLC]21 package rows20240619_f8fe4fff-e83f-36b8-e053-6394a90aa932.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80861-11180861-111-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
1b2f6f06-30bf-c59d-e063-6294a90a598bf8fe4fff-e83f-36b8-e053-6394a90aa9322024-06-18WarningsExact identifier
spl id: 1b2f6f06-30bf-c59d-e063-6294a90a598b
spl set id: f8fe4fff-e83f-36b8-e053-6394a90aa932

Reported adverse events (FAERS/openFDA)#

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