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| Product NDC Code | 81996-244 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Nuturna arthritis intensive concentrate for pain relief and recovery |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| RxCUI drug identifier | 1655936 | ||||||||
| Application Number | M017 | ||||||||
| Labeler Name | Nuturna International 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 3.70% 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.Directions: Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor. We recommend testing a small amount of cream on your skin first to check for skin reaction and comfort level, wait 15 minutes before applying to affected area if you are happy with the comfort level.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Aloe Barbadensis Leaf(Aloe Vera Gel)Juice, Arnica Montana Flower Extract, Carbomer, Ilex Paraguariensis (Yerba Mate) Extract, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Oil, Methylisothiazolinone, Methylsulfonylmethane (MSM), Polysorbate-20, Tocopheryl Acetate (Vitamin E), Triethanolamine, FD & C Blue # 1.
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 the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises and 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.NUTURNA Arthritis Intensive Concentrate for Pain Relief and Recovery MENTHOL ALOE VERA LEAF ARNICA MONTANA FLOWER ILEX PARAGUARIENSIS LEAF ISOPROPYL ALCOHOL TEA TREE OIL METHYLISOTHIAZOLINONE DIMETHYL SULFONE POLYSORBATE 20 .ALPHA.-TOCOPHEROL ACETATE TROLAMINE FD&C BLUE NO. 1 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:57g Label
Package Labeling:114g Label2
Package Labeling:228g Label3
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: Protect the product in this container from excessive heat and direct sun.
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 damaged or broken 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. 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 ? [email protected]
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 Rash or irritation develops and lasts. Condition worsens, or if symptoms persist for more than 7 days or clear up and occurs 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 Avoid contact with the eyes. Do not bandage tightly
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 Do not use On damaged or broken skin. When using this product Avoid contact with the eyes. Do not bandage tightly Stop use and ask a doctor if Rash or irritation develops and lasts. Condition worsens, or if symptoms persist for more than 7 days or clear up and occurs again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 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