Pain Relieving Cream Analgesic
Pain Relieving Cream Analgesic is an FDA drug label for the active ingredient MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE manufactured by Garcoa, 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 20260818.
- Generic name
- MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE
- Manufacturer
- Garcoa, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 67385-701
- Application
- M017
- Label effective
- 20260818
About this product
Pain Relieving Cream Analgesic is an FDA-registered drug product whose active ingredient is MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE. It is labelled by Garcoa, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 67385-701, application M017, label effective 20260818. 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 MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE are most often described in connection with: temporary relief, minor aches, pains muscles, joints associated, simple backache, arthritis strains. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Use(s) For the temporary relief of minor aches and pains of muscles and joints; associated with simple backache, arthritis, strains, bruises, and sprains.
Dosage & Administration
Directions Adults and children 6 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 6 years of age: consult a doctor.
Warnings
Warnings For external use only For external use only. ALLERGY ALERT If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. When using this product •Avoid contact with eyes •Use only as directed •Perform a patch test prior to use. A transient burning sensation may occur upon application. With regular use, this sensation generally disappears after several days. •Do not apply to wounds or damaged skin •Do not bandage tightly •Do not use with a heating pad. Stop use and ask a doctor if •severe burning persists or blistering occurs •condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Pregnancy/Breastfeeding If pregnant or breastfeeding ask a health professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Frequently asked questions
What is Pain Relieving Cream Analgesic used for?
Use(s) For the temporary relief of minor aches and pains of muscles and joints; associated with simple backache, arthritis, strains, bruises, and sprains.
Who makes Pain Relieving Cream Analgesic?
Garcoa, Inc. is the labeler of record for Pain Relieving Cream Analgesic.
What form does Pain Relieving Cream Analgesic 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 Pain Relieving Cream Analgesic 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 Pain Relieving Cream Analgesic 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.