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| Product NDC Code | 69420-7025 | ||||
|---|---|---|---|---|---|
| Drug Name | Capsaicin |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 1043399 | ||||
| Application Number | part348 | ||||
| Labeler Name | SA3, LLC | ||||
| Packages |
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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 18 years of age and older: Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time. Clean and dry the affected area. Open pouch and remove one patch. Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope. Wash hands with soap and water after handling the patches. Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope. Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. Children under 18 years : Ask a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aqua (Deionized Water), Sodium Polyacrylate, Glycerin, Sorbitol, Sodium Cellulose Glycolate, Polysorbate 80, Lemon Oil, Aluminum Glycinate, Eucalyptus Oil, Methylparaben, EDTA Disodium Salt
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 Temporarily relieves minor aches and pains of muscles and joints due to: • arthritis • simple backache • 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.Capsaicin Capsaicin CAPSAICIN CAPSAICIN WATER GLYCERIN SORBITOL CARBOXYMETHYLCELLULOSE SODIUM POLYSORBATE 80 LEMON OIL DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS EUCALYPTUS OIL METHYLPARABEN EDETATE DISODIUM SODIUM POLYACRYLATE (8000 MW)
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.PRINCIPAL DISPLAY PANEL Capsaicin 0.025 % Patch NDC 69420-7025-1 10 Patches (5 per Resealable Pouch) SA3, LLC PRINCIPAL DISPLAY PANEL Capsaicin 0.025% Patch NDC 69420-7025-1 10 Patches (5 per Resealable Pouch) SA3, LLC
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.CAPSAICIN – Capsaicin 0.025% Patch SA3, LLC Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Capsaicin 0.025% Patch Drug Facts
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 wounds, cuts, damaged or infected skin • On eyes, mouth, genitals, or any other mucous membranes Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use.
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 and pets . If swallowed, get medical help or contact a Poison Control Center immediately.
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.Whe n us ing this product • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days. • Avoid contact with the eyes, lips, nose and mucous membranes • Do not tightly wrap or bandage the treated area • Do not apply heat to the treated area immediately before or after use
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature 15°-30°C (59°-86°F)
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 . Use only as directed or as directed by a health care professional Read all warnings and directions before use. Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming. Do not use • On wounds, cuts, damaged or infected skin • On eyes, mouth, genitals, or any other mucous membranes Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use. Whe n us ing this product • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days. • Avoid contact with the eyes, lips, nose and mucous membranes • Do not tightly wrap or bandage the treated area • Do not apply heat to the treated area immediately before or after use Stop use and as k a physician: • If pregnant or breast feeding • 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 physician. • If severe burning persists or blistering occurs Keep out of reach of children and pets . If swallowed, get medical help or contact a Poison Control Center immediately.
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