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Product NDC Code | 24909-191 | ||||
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Drug Name | Terrasil flex pain relief and muscle rub |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 1148430 | ||||
Application Number | part348 | ||||
Labeler Name | Aidance Skincare & Topical Solutions, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient and purpose : Menthol 4% (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.Directions Adults & 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Purified water, emulsifying wax, shea butter, cotton seed oil, sorbic acid (preservative), chamomile oil, jojoba oil, sage oil, vitamin B oil, olive oil, vegetable stearic acid (naturally sourced), magnesium oxide, silver oxide, 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 backaches, arthritis, strains and bruises.
Spl product data elements
Usually a list of ingredients in a drug product.Terrasil FLEX Pain Relief and Muscle Rub Menthol MENTHOL MENTHOL WATER CETYL STEARATE SHEA BUTTER COTTONSEED OIL SORBIC ACID CHAMOMILE FLOWER OIL JOJOBA OIL SAGE OIL PANTHENOL OLIVE OIL STEARIC ACID MAGNESIUM OXIDE SILVER OXIDE 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.PRINCIPAL DISPLAY PANEL Natural terrasil® FLEX PAIN RELIEF & MUSCLE RUB CREAM For Arthritis, Sore Muscles, Joint & Back Pain Terrasil
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 the 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