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Product NDC Code | 11993-001 | ||||||
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Drug Name | Astrapharm chilli brand external medicated |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | PLASTER | ||||||
Application Number | part348 | ||||||
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%
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 Peel apart from paper backing and apply directly to the affected area. If needed, cut plaster into small pieces and apply to affected area. It will be more effective when used after a bath. Adults and children 2 years and older: Apply to affected area no more than 3 to 4 times daily. Children under 2 years: Do not use, consult a doctor.
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 EXTERNAL MEDICATED Capsaicin CAPSAICIN CAPSAICIN .BETA.-PINENE CALCIUM CARBONATE NAPHTHA POLYBUTENE (1400 MW) NATURAL LATEX RUBBER FERRIC OXIDE RED ZINC OXIDE
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 MEDICATED PLASTER NDC 11993-001-01 Simple backache, Arthritis, Strains, Bruises, Sprains 1 Sheet - 4.5 in x 7 in (11.4 cm x 17.8 cm) 1 Sheet Pouch
ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED PLASTER NDC 11993-001-02 Simple backache, Arthritis, Strains, Bruises, Sprains 5 Sheets - (3.4 x 4.5 in Each) 5 Sheet Pouch
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 on irritated or damaged 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 Not recommended for people with sensitive skin. May cause rash or festering. Not recommended for use when in contact with hot water. Burning sensation may occur. Do not apply on extremely hairy surface of skin. Highly adhesive plaster may hurt skin upon removal of product. Preserve in tight container after opening. 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? (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 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 pain persists for more than 10 days 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
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 Allergy alert: This product contains natural rubber latex which may cause allergic reactions
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