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| Product NDC Code | 55614-410 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Solstice capsaicin patch hot |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | PATCH | ||||||
| RxCUI drug identifier | 1043399 | ||||||
| Application Number | part348 | ||||||
| Labeler Name | MADISON ONE ACME INC | ||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Report any unexpected side effects from the use of this product to the FDA MedWatch Program
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Capsaicin 0.025%
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 12 years of age and older: clean and dry affected area remove the protective film from the patch apply patch to affected area not more than 3 to 4 times daily remove patch from the skin after at most 8-hour application wet patch with warm water before removing from the skin children under 12 years of age: consult your physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, and styrene/isoprene copolymer.
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.Uses For the temporary relief of minor aches and pains of muscles and joints due to: simple backache arthritis strains bruises sprains
Purpose
Information about the drug product’s indications for use.Purpose External analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Solstice Capsaicin Patch Hot Capsaicin CAPSAICIN CAPSAICIN HYDROGENATED POLYDECENE (550 MW) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) LIQUID PETROLEUM STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)
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.Solstice Capsaicin Patch Hot Capsaicin 0.025% NDC 55614-410-01 1 Patches, Each Patch 5.12 in x 7.09 in (13 cm x 18 cm) IMAGE OF 1 PATCH POUCH
Solstice Capsaicin Patch Hot Capsaicin 0.025% NDC 55614-410-03 3 Patches, Each Patch 5.12 in x 7.09 in (13 cm x 18 cm) IMAGE OF 3 PATCH POUCH
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you have any concerns about using this product
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on irritated or damaged skin on wounds
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? (888) 221-3496 M-F 9 am to 5 pm you may also report serious side effects to this phone number
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 condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive irritation of the skin develops nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation) when using for pain of arthritis: pain persists for more than 10 days redness is present in conditions affecting children under 12 years of age
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 avoid contact with the eyes or mucous membranes do not bandage tightly do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns) avoid placing on extremely hairy areas of skin to avoid irritation upon removing the patch
Storage and handling
Information about safe storage and handling of the drug product.Other information keep patches tightly closed in the zip-lock pouch avoid excessive heat
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
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