RoyceDerm Seborrheic Scalp .spray.
RoyceDerm Seborrheic Scalp .spray. is an FDA drug label for the active ingredient SALICYLIC ACID 2% manufactured by RoyceDerm LLC 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 20260626.
- Generic name
- SALICYLIC ACID 2%
- Manufacturer
- RoyceDerm LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 85424-028
- Application
- M032
- Label effective
- 20260626
About this product
RoyceDerm Seborrheic Scalp .spray. is an FDA-registered drug product whose active ingredient is SALICYLIC ACID 2%. It is labelled by RoyceDerm LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 85424-028, application M032, label effective 20260626. It is one of 11 FDA drug label records sharing the active ingredient SALICYLIC ACID 2%. 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 2% are most often described in connection with: children years, older apply, affected areas, one four, times daily, directed doctor, spray directly, scalp area. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Adults and children 12 years & older: apply to affected areas one to four times daily or as directed by a doctor. spray directly onto the affected scalp area. massage gently if needed. do not rinse.
Dosage & Administration
controls the symptom of seborrheic dermatitis. helps prevent recurrence of skin and scalp itching,irritation, redness, flaking, scaling associated with seborrheic dermatitis
Warnings
For external use only. if you have a condition that covers a large area of the body. avoid contact with the eye. If contact occurs, rinse the eyes thoroughly with water. Stop and ask a doctor if condition worsens or does not improve after regular use of this product as directed. If swallowed, get medical help or contact a Poison Control Center right away.
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View labelHow products containing SALICYLIC ACID 2% compare
FDA lists 11 drug label records with SALICYLIC ACID 2% as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | RoyceDerm LLC | 2 |
| — | — | BellamiLuxx LLC | 1 |
| — | — | Defense Soap LLC | 1 |
| — | — | GENUINE INNOVATION LTD | 1 |
| — | — | Guangzhou Huixue Biotechnology Co., Ltd. | 1 |
Frequently asked questions
What is RoyceDerm Seborrheic Scalp .spray. used for?
Adults and children 12 years & older: apply to affected areas one to four times daily or as directed by a doctor. spray directly onto the affected scalp area. massage gently if needed. do not rinse.
Who makes RoyceDerm Seborrheic Scalp .spray.?
RoyceDerm LLC is the labeler of record for RoyceDerm Seborrheic Scalp .spray.. 11 FDA label records share the active ingredient SALICYLIC ACID 2%, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does RoyceDerm Seborrheic Scalp .spray. 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 RoyceDerm Seborrheic Scalp .spray. 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.
Are there other products containing SALICYLIC ACID 2%?
Yes. 11 FDA drug label records list SALICYLIC ACID 2% as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has RoyceDerm Seborrheic Scalp .spray. 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.