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| Product NDC Code | 72609-703 | ||||
|---|---|---|---|---|---|
| Drug Name | Foot |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 416982 | ||||
| Application Number | M017 | ||||
| Labeler Name | Smith Amish, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active Ingredient Menthol 1.25%
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 Adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Arnica montana flower extract, cetyl palmitate, ethylhexylglycerin, glycerin, glyceryl stearate, jojoba (Buxus chinensis) oil, peppermint (mentha piperita) oil, phenoxyethanol, sodium citrate, stearic acid, sweet almond (Prunus amydgalus dulcis) oil, tea tree (Melaleuca alternifolia) oil, tocopherol (Vitamin E), water
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 For temporary relief of minor aches and pains
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.FOOT MENTHOL ETHYLHEXYLGLYCERIN ALMOND OIL MENTHOL MENTHOL JOJOBA OIL GLYCERYL MONOSTEARATE PEPPERMINT OIL .ALPHA.-TOCOPHEROL ARNICA MONTANA WHOLE CETYL PALMITATE SODIUM CITRATE STEARIC ACID TEA TREE OIL WATER GLYCERIN PHENOXYETHANOL
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.Label Smith Amish Arthritis Cream (72609-702-02) Provides Penetrating Relief Arthritic pain Muscle Pain Joint Pain Back Pain Fresh scent from Arnica & Eucalyptus All natural and non-greasy Net wt. 2oz (59g) label
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.Tamper evident: Do not use if safety seal under cap is broken or missing. Manufactured for Smith Amish LLC 16350 N Hwy 329 Reddick, FL 32634
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 Protect from excessive heat Store at 20-25 o C (68-77F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call (866) 419-3567 Monday through Friday 8:00am - 2:00pm ET
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.If condition worsens, or if symptoms persist for more than 7 days or cler up and occur again within a few days,, discontinue use of this product and consult a doctor.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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 Avoid contact with eyes If condition worsens, or if symptoms persist for more than 7 days or cler up and occur again within a few days,, discontinue use of this product and consult a doctor. If pregnant or breast-feeding, ask a health professional before use.
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