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| Product NDC Code | 0178-0320 | ||||
|---|---|---|---|---|---|
| Drug Name | Theragesic |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 259203, 724160 |
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| Application Number | M017 | ||||
| Labeler Name | Mission Pharmacal Company | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active Ingredients Purpose Menthol 1%............................................................................................................................................................................................................................................................................................................................................................................... Analgesic Methyl Salicylate 15%......................................................................................................................................................................................................................................................................................................................................................... Counterirritant
| Menthol 1%............................................................................................................................................................................................................................................................................................................................................................................... Analgesic | |
| Methyl Salicylate 15%......................................................................................................................................................................................................................................................................................................................................................... Counterirritant | |
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.Directions Adults and children 12 or more years of age. Apply thin layers of crème into and around the sore or painful area, not more than 3 to 4 times daily. The number of thin layers controls the intensity of the action of THERA-GESIC ® . One this layer provides a mild effect, two thin layers provide a strong effect and three thin layers provide a very strong effect. SEE WARNINGS. Wash hands thoroughly after application.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients
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.Other information Showering or washing the area after application of THERA-GESIC ® will leave the area fragrance-free without diminishing the therapeutic effect. Avoid contact with clothing or other surfaces. Store at 20-25°C (68-77°F).
Purpose
Information about the drug product’s indications for use.Use temporary relief of minor aches and pains of muscles and joints associated with: arthritis simple backaches strains bruises sprains
Spl product data elements
Usually a list of ingredients in a drug product.Theragesic METHYL SALICYLATE WATER DIMETHICONE GLYCERIN CARBOMER 934 TROLAMINE METHYLPARABEN SODIUM LAURYL SULFATE PROPYLPARABEN METHYL SALICYLATE SALICYLIC ACID MENTHOL MENTHOL
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.THERA-GESIC 3-oz carton
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.Ask a doctor before use for children under 2 and to 12 years of age if prone or sensitive to allergic reaction from aspirin or salicylate
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 immediately shower or bath if skin is sensitive to oil of wintergreen (methyl salicylate) on wounds 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 to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions (210) 696-8400 (M-Th 8:00-5:30 CST)
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, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
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 discontinue use if skin irritation develops, or redness is present do not swallow do not use a heating pad after application of THERA-GESIC ®
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.THERA-GESIC 3-oz label
Precautions
Information about any special care to be exercised for safe and effective use of the drug.SHARE BEFORE USE: IT IS NORMAL FOR THIS PRODUCT TO GIVE THE IMPRESSION OF A LIQUID SOUND UON SHAKING. DO NOT ALLOW THERA-GESIC ® TO COMEIN CONTACT WITH ANY SURFACE, OTHER THAN SKIN. Do not use this product if tube is punctured. Lot number and expiration date on end of carton. MISSION PHARMACAL COMPANY, San Antonio, TX 78230 1355 50588 03 Rev 001090
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. Avoid contact with eyes or mucous membranes. Do not bandage, wrap, cover, use a heating pad after, or recline upon skin treated with THERA-GESIC ® .
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