Cycle
Cycle is an FDA drug label for the active ingredient MENTHOL manufactured by La Mend, 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 20231207.
- Generic name
- MENTHOL
- Manufacturer
- La Mend, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 72587-001
- Application
- M017
- Label effective
- 20231207
About this product
Cycle is an FDA-registered drug product whose active ingredient is MENTHOL. It is labelled by La Mend, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 72587-001, application M017, label effective 20231207. It is one of 193 FDA drug label records sharing the active ingredient MENTHOL. 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 are most often described in connection with: temporary relief, minor aches, pains muscles, joins associated, cramps simple. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Use For the temporary relief of minor aches and pains of muscles and joins associated with: cramps simple backache
Dosage & Administration
Directions Adults and children over 12 years remove backing from patch apply patch to affected area like abdomen or lower back wear patch for up to 8 hours use no more than 3-4 times daily Children 12 years or younger: ask a doctor
Warnings
Warnings For external use only. When using this product use only as directed do not use with other topical products do not use on open wounds, damaged or irritated skin do not bandage tightly or apply local heat to this area, like heating pads in rare cases, burns have been reported for products of this type, containing menthol Stop use and ask a doctor if confiditon worsens redness or irritation develop symptoms last more than 7 days or clear up and occur again within a few days you experience burning, swelling, or blistering where applied 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 Center right away.
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View labelHow products containing MENTHOL compare
FDA lists 193 drug label records with MENTHOL 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 |
|---|---|---|---|
| — | — | Reckitt Benckiser LLC | 23 |
| — | — | Mondelez Global LLC | 6 |
| — | — | BLUE SPRING WELLNESS, L.L.C. | 5 |
| — | — | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | 5 |
| — | — | Bestco | 4 |
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-1057-2019 | Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-860-12), Rx only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA. | Lupin Pharmaceuticals Inc. | Class II | Terminated | 20190403 |
| D-0025-2019 | Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53. | Mylan Pharmaceuticals Inc. | Class III | Terminated | 20181024 |
| D-496-2013 | Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66 | Teva Pharmaceuticals USA, Inc. | Class III | Terminated | 20130605 |
| D-497-2013 | Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser NDC 0093-3134-91), 91 Tablets Each, Rx only, TEVA Womens Health Inc., Subsidiary of TEVA Pharmaceuticals, Inc., Sellersville, PA | Teva Pharmaceuticals USA, Inc. | Class III | Terminated | 20130605 |
| D-246-2013 | Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66. | Teva Pharmaceuticals USA, Inc. | Class III | Terminated | 20130417 |
Frequently asked questions
What is Cycle used for?
Use For the temporary relief of minor aches and pains of muscles and joins associated with: cramps simple backache
Who makes Cycle?
La Mend, Inc. is the labeler of record for Cycle. 193 FDA label records share the active ingredient MENTHOL, 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 Cycle 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 Cycle 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 MENTHOL?
Yes. 193 FDA drug label records list MENTHOL 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 Cycle been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
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.