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Product NDC Code | 11993-000 | ||||||
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Drug Name | Astrapharm chilli brand |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | PLASTER | ||||||
RxCUI drug identifier | 1111739 | ||||||
Application Number | M017 | ||||||
Labeler Name | Dersan Pharmaceutical Co., Ltd | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Capsaicin 0.25%..............................External analgesic
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: Clean and dry affected area, peel plaster away from paper backing and apply to the affected area by pressing edges down firmly. If needed, cut plaster into smaller pieces. Adults and children 12 years of age and over: Apply to affected area not more than 3 times daily. Children under 12 years, consult doctor before use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Beta-pinene homopolymer, calcium carbonate, light steam-cracked aromatic naphtha(petroleum), polybutenes, rubber(natural), synthetic iron oxide, and 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 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.ASTRAPHARM CHILLI BRAND CAPSAICIN .BETA.-PINENE CALCIUM CARBONATE NAPHTHA POLYBUTENE (1400 MW) NATURAL LATEX RUBBER BROWN IRON OXIDE 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.Astrapharm "Chilli Brand" External Analgesic Plaster 4.5in x 7in 1.jpg Astrapharm Chilli Brand PDP Inner Package 4.5in x 7in 2.jpg Inner Package Astrapharm "Chilli Brand" External Analgesic Plaster 4.5in x 3.4in 3.jpg Astrapharm Chilli Brand PDP Inner Package 4.5in x 3.5in 4.jpg image description
Inner Package 4.5in x 7in 2.jpg Inner Package
Astrapharm "Chilli Brand" External Analgesic Plaster 4.5in x 3.4in 3.jpg Astrapharm Chilli Brand PDP
Inner Package 4.5in x 3.5in 4.jpg image description
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask doctor if
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 damaged or irritated skin
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information: Once opened, keep the unused plaster in an air-tight container. Store at 20-25°C(68-77°F)
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? M-F, 9 am to 5 pm Pacific Time 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 Excessive irritation of the skin develops Condition worsens Symptoms persist for more than 7 days Symptoms clear up and occur again within a few days When using for pain of arthritis: if 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 may cause rash or festering. Not recommended for people with sensitive skin. burning sensation may occur. Not recommended for use when in contact with hot water. highly adhesive plaster may hurt skin upon removal of product. Do not apply on hairy surface of skin.
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