The Acne Spot Treatment
The Acne Spot Treatment is an FDA drug label for the active ingredient SALICYLIC ACID SPOT manufactured by Spotless, Inc. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260830.
- Generic name
- SALICYLIC ACID SPOT
- Manufacturer
- Spotless, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 87415-100
- Application
- M006
- Label effective
- 20260830
About this product
The Acne Spot Treatment is an FDA-registered drug product whose active ingredient is SALICYLIC ACID SPOT. It is labelled by Spotless, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 87415-100, application M006, label effective 20260830. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing SALICYLIC ACID SPOT are most often described in connection with: treatment acne. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses • for treatment of acne
Dosage & Administration
Drug Facts Drug Facts
Warnings
Warnings For external use only Flammable, keep away from open fire or flame When using this product skin irritation and dryness is more likely to occur if you use another topical medication at the same time. If irritation occurs, only use one topical acne medication at a time. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.
Frequently asked questions
What is The Acne Spot Treatment used for?
Uses • for treatment of acne
Who makes The Acne Spot Treatment?
Spotless, Inc. is the labeler of record for The Acne Spot Treatment.
What form does The Acne Spot Treatment come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is The Acne Spot Treatment prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has The Acne Spot Treatment been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.