Eagle Brand Medicated Roll On Aromatic

CAMPHOR, MENTHOL, METHYL SALICYLATE TOPICAL HUMAN OTC DRUG

Eagle Brand Medicated Roll On Aromatic is an FDA drug label for the active ingredient CAMPHOR, MENTHOL, METHYL SALICYLATE manufactured by PT. EAGLE INDO PHARMA 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 20260427.

Generic name
CAMPHOR, MENTHOL, METHYL SALICYLATE
Manufacturer
PT. EAGLE INDO PHARMA
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
60954-017
Application
M017
Label effective
20260427

About this product

Eagle Brand Medicated Roll On Aromatic is an FDA-registered drug product whose active ingredient is CAMPHOR, MENTHOL, METHYL SALICYLATE. It is labelled by PT. EAGLE INDO PHARMA taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 60954-017, application M017, label effective 20260427. It is one of 13 FDA drug label records sharing the active ingredient CAMPHOR, MENTHOL, METHYL SALICYLATE. 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 CAMPHOR, MENTHOL, METHYL SALICYLATE are most often described in connection with: temporary relief, minor aches, pains muscles, joints associated, simple backache, arthritis strains, bruises sprains. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients Camphor 7% Menthol 16% Methyl Salicylate 35%

Indications & Usage

Uses For temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains.

Dosage & Administration

Directions Adults and children 2 years of age and older:apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.

Warnings

Warnings For external use only When using this product Avoid getting into the eyes or on mucous membranes. Do not apply to wounds or damaged skin. Do not bandage tightly. Do not use otherwise than as directed. Stop use and ask doctor if Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Excessive skin irritation develops. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Centre right away.

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How products containing CAMPHOR, MENTHOL, METHYL SALICYLATE compare

FDA lists 13 drug label records with CAMPHOR, MENTHOL, METHYL SALICYLATE 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 formProductsManufacturerProducts
— — PT. EAGLE INDO PHARMA 2
— — Sinsin Pharmaceutical Co., Ltd. 2
— — Amerisource Bergen 1
— — Big 5 Nutrition LLC 1
— — Borden Company (Private) Limited 1

Frequently asked questions

What is Eagle Brand Medicated Roll On Aromatic used for?
Uses For temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains.

Who makes Eagle Brand Medicated Roll On Aromatic?
PT. EAGLE INDO PHARMA is the labeler of record for Eagle Brand Medicated Roll On Aromatic. 13 FDA label records share the active ingredient CAMPHOR, MENTHOL, METHYL SALICYLATE, 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 Eagle Brand Medicated Roll On Aromatic 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 Eagle Brand Medicated Roll On Aromatic 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 CAMPHOR, MENTHOL, METHYL SALICYLATE?
Yes. 13 FDA drug label records list CAMPHOR, MENTHOL, METHYL SALICYLATE 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 Eagle Brand Medicated Roll On Aromatic 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.