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| Product NDC Code | 24909-199 | ||||
|---|---|---|---|---|---|
| Drug Name | Terrasil back pain cream |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1148430 | ||||
| Application Number | M017 | ||||
| Labeler Name | Aidance Skincare & Topical Solutions, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Menthol 4%
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 12 years of age and older. Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age - consult a physician. May stain fabrics.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Chamomile oil, cotton seed oil, emulsifying wax, jojoba oil, magnesium oxide, olive oil, purified water, sage oil, shea butter, silver stearate, sorbic acid (preservative), vitamin B oil, 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 associated with simple back ache.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Terrasil Back Pain Cream Menthol COTTONSEED OIL JOJOBA OIL CHAMOMILE FLOWER OIL MAGNESIUM OXIDE OLIVE OIL WATER SAGE OIL SHEA BUTTER ZINC OXIDE SORBIC ACID SILVER OXIDE PANTHENOL CETYL STEARATE MENTHOL, UNSPECIFIED FORM 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.Product label image description
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.401-432-7750 or www.aidance.com
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 consult a physician.
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. Do not use on wounds or damaged skin and avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. If swallowed consult a physician.
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