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Product NDC Code | 79643-002 | ||||
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Drug Name | Capsaicin |
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Type | Generic | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | PATCH | ||||
RxCUI drug identifier | 1043399 | ||||
Labeler Name | PHARMACURE 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. INSTRUCTIONS FOR USE : 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. Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming. 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 Adhesive, myrrh gum, zinc oxide.
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 mild to moderate aches and pains of muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, bruises.
Purpose
Information about the drug product’s indications for use.Purpose Topical Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Capsaicin Capsaicin MYRRH ZINC OXIDE CAPSAICIN CAPSAICIN
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.Label image description
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 (1-800-222-1222) immediately.
Storage and handling
Information about safe storage and handling of the drug product.Other information Some individuals may not experience pain relief until several minutes or hours after applying the patch. Store in a cool, dry place. Protect the product from excessive moisture or sunlight. Store at 67-77°F (19-25°C).
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. 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. When using 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 ask a physician : • rash, itching or excessive skin irritation develops. • conditions worsen. • symptoms persist for more than 7 days. • symptoms clear up and occur again within a few days. If pregnant or breast-feeding, ask a health professional before use.
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