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| Product NDC Code | 11822-7884 | ||||
|---|---|---|---|---|---|
| Drug Name | Capsaicin |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 646333 | ||||
| Application Number | part348 | ||||
| Labeler Name | Rite Aid | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Purpose Capsaicin 0.1%....................................................Topical 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.Distributed by: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 Made in China
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactivate ingredients benzyl alcohol, cetyl alcohol, isopropyl myristate, petrolatum, polyoxyl 40 stearate, purified water, sorbitan monostearate, sorbital
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.Directions adults and children 18 years of age and older: use only as directed apply to affected area massage into painful area until thoroughly absorbed repeat as necessary, but no more than 3 to 4 times daily wash hands with soap and water after applying children under 18 years of age: ask a doctor
Purpose
Information about the drug product’s indications for use.Uses temporarily relieves minor pain of muscles and joints associated with: arthritis simple backache strains sprains bruises
Spl product data elements
Usually a list of ingredients in a drug product.Capsaicin Arthritis Pain Relief CETYL ALCOHOL POLYOXYL 40 STEARATE WATER SORBITOL PETROLATUM SORBITAN MONOSTEARATE ISOPROPYL MYRISTATE CAPSAICIN CAPSAICIN BENZYL ALCOHOL
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.78846
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, broken or irritated skin with a heating pad if you are allergic to capsicum or chili peppers
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 (1-800-222-1222) right away.
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 or clear up and occur again within a few days redness is present or irriration develops a severe burning sensation occurs
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 a transient burning sensation may occur upon application but generally disappears in several days do not expose the treated area to heat or direct sunlight
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature 20-25°C (68-77°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
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