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| Product NDC Code | 72587-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Cycle |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 420222 | ||||
| Application Number | M017 | ||||
| Labeler Name | La Mend, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) Menthol (5%)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Inactive Ingredients: 2-propenoic acid, 2-methyl-, methyl ester, polymer with ethenyl acetate and 2-ethylhexyl 2-propenoate, black cohosh (cimicifuga racemosa)
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use For the temporary relief of minor aches and pains of muscles and joins associated with: cramps simple backache
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Cycle Menthol 1,1'-((1-METHYL-1,2-ETHANEDIYL)2-PROPENOIC ACID, BIS(OXY(1-METHYL-2,1-ETHANEDIYL))) ESTER MENTHOL MENTHOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package Label - Principal Display Panel THE GOOD PATCH 2.3" x 3.7" 4-Way Stretch Fabric Patch Cycle QTY. 04 PATCHES Periods are a pain! Get fast-acting pain relief with this water-resistant topical patch. Made with plant-derived Menthol and Black Cohosh. 1 2
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Directions (December 2023)
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store in a cool, dry place.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API