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| Product NDC Code | 70329-717 | ||||
|---|---|---|---|---|---|
| Drug Name | Teeter renew muscles pain relieving |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1608491 | ||||
| Application Number | M017 | ||||
| Labeler Name | STL International INC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Methyl Salicylate 10.0% Menthol 7.0% Purpose 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.Use only as directed Directions • Adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aqua (deionized water), arnica montana (arnica) extract, boswellia serrata extract, C13-14 isoparaffin, cetyl alcohol, citrus aurantium dulcis (orange) peel oil, chondroitin sulfate, dimethyl sulfone (MSM), emu oil, ethoxydiglycol, gluconolactone, glucosamine sulfate, glycerin, glyceryl stearate, isopropyl myristate, laureth-7, PEG-100 stearate, polyacrylamide, polysorbate-20, sodium benzoate, stearic acid
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 Temporary relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains
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.Teeter reNEW MUSCLES Pain Relieving METHYL SALICYLATE, MENTHOL WATER ARNICA MONTANA INDIAN FRANKINCENSE C13-14 ISOPARAFFIN CETYL ALCOHOL ORANGE OIL DIMETHYL SULFONE EMU OIL DIETHYLENE GLYCOL MONOETHYL ETHER GLUCONOLACTONE GLUCOSAMINE SULFATE GLYCERIN GLYCERYL MONOSTEARATE ISOPROPYL MYRISTATE LAURETH-7 PEG-100 STEARATE POLYSORBATE 20 SODIUM BENZOATE STEARIC ACID 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.Package Labeling: 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.Drug Facts
Other information Store at 20° to 25°C (68°-77°F)
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 or damaged skin • with a heating pad
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. In case of accidental ingestion, get medical help or contact a Poison Control Center 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 physician if • condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • excessive skin irritation occurs • pregnant or breastfeeding
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 eyes and mucus membranes • do not bandage tightly
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. Allergy Alert: If you had prior allergic reaction to aspirin or salicylate, please consult a doctor before use. Do not use • on wounds or damaged skin • with a heating pad Ask a physician before use if you have redness over the affected area. When using this product • avoid contact with eyes and mucus membranes • do not bandage tightly Stop use and ask a physician if • condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • excessive skin irritation occurs • pregnant or breastfeeding Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
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