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| Product NDC Code | 58980-615 | ||||
|---|---|---|---|---|---|
| Drug Name | Arctic relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 808955 | ||||
| Application Number | M017 | ||||
| Labeler Name | STRATUS PHARMACEUTICALS INC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Natural Menthol USP 3.5%
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: Rub a thin film over affected areas not more than 4 times daily; massage not necessary. Children under 2 years of age: Consult physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Camphor, carbomer, FD&C blue #1, FD&C yellow #5, herbal extract, isopropyl alcohol, methyl paraben, silicon dioxide, trolamine and purified 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 Temporary relief from minor aches and pains of sore muscles & joints associated with arthritis backache strains sprains.
Purpose
Information about the drug product’s indications for use.Purpose Cooling Pain Reliever
Spl product data elements
Usually a list of ingredients in a drug product.ARCTIC RELIEF MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM CAMPHOR (SYNTHETIC) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) FD&C BLUE NO. 1 FD&C YELLOW NO. 5 ILEX PARAGUARIENSIS LEAF ISOPROPYL ALCOHOL
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 - 113.4 gram Tube Box Arctic Relief PAIN RELIEVING GEL NDC 58980-615-40 Net WT. 4 oz. / 113.4 grams •GREASELESS •STAINLESS •VANISHING SCENT PENETRATING, LONG-LASTING PAIN RELIEF FROM: ARTHRITIS, SORE MUSCLES & JOINTS AND BACK PAIN. STRATUS PHARMACEUTICALS INC PRINCIPAL DISPLAY PANEL - 113.4 gram Tube Box
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
Distributed by: Stratus Pharmaceuticals Inc. Miami, FL 33186
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have sensitive 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 accidentally ingested, get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Call Customer Service at 800-442-7882
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 Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.
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 or mucous membranes Do not apply to wounds or damaged skin Do not use with other ointments, creams, sprays or liniments Do not apply to irritated skin or if excessive irritation develops Do not bandage Wash hands after use with cool water Do not use with a heating pad or device.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding Ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store in a cool dry place with cap closed 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 . Flammable: Keep away from excessive heat or open flame. Ask a doctor before use if you have sensitive skin. When Using This Product Avoid contact with the eyes or mucous membranes Do not apply to wounds or damaged skin Do not use with other ointments, creams, sprays or liniments Do not apply to irritated skin or if excessive irritation develops Do not bandage Wash hands after use with cool water Do not use with a heating pad or device. Stop Use And Ask A Doctor If Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.
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