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Product NDC Code | 72793-201 | ||||||||||
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Drug Name | Mountain ice sports recovery |
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Type | Brand | ||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||
Dosage Form | GEL | ||||||||||
RxCUI drug identifier | 415976 | ||||||||||
Application Number | M017 | ||||||||||
Labeler Name | Mountainside Medical Equipment, Inc. | ||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Menthol 6%
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 or older. Rub on the affected area evenly no more than 4 times per day. Children under 2 years of age: Consult with your doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata (Frankincense) Oil, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Cinnamomum Camphora (camphor) Bark Oil, Curcuma Longa (Turmeric) Root Oil, Dimethyl Sulfone, Dipotassium Glycyrrhizate, Ethylhexylglycerin, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Glycerin, Isopropyl Alcohol, L-Arginine, Limonene, Magnesium Sulfate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha Spicata (Spearmint) Oil, Niacinamide, Panax Ginseng Root Extract, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate, Triethanolamine, Water (Aqua), Blue 1 (CI 42090).
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 osteoarthritis, rheumatoid arthritis, muscle strains, and sprains.
Purpose
Information about the drug product’s indications for use.Purpose External Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Mountain Ice Sports Recovery Menthol MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ALOE VERA LEAF ARNICA MONTANA FLOWER INDIAN FRANKINCENSE OIL GREEN TEA LEAF CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CAMPHOR OIL TURMERIC OIL DIMETHYL SULFONE GLYCYRRHIZINATE DIPOTASSIUM ETHYLHEXYLGLYCERIN EUCALYPTUS OIL GLYCERIN ISOPROPYL ALCOHOL ARGININE LIMONENE, (+)- MAGNESIUM SULFATE, UNSPECIFIED FORM TEA TREE OIL MENTHA SPICATA OIL NIACINAMIDE ASIAN GINSENG PHENOXYETHANOL POLYSORBATE 20 .ALPHA.-TOCOPHEROL ACETATE TROLAMINE WATER FD&C BLUE NO. 1
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 SPORT MUSCLE PAIN RELIEF THERAPY GEL MOUNTAIN ICE GINSENG, ARNICA, TURMERIC, VITAMIN B3, BOSWELLIA INDIAN FRANKINCENSE OIL, GREEN TEA EXTRACT, MSM, VITAMIN E, ALOE VERA, TEA TREE OIL, MENTHOL 6%, L-ARGININE AMINO ACID, LICORICE ROOT EXTRACT, EUCALYPTUS LEAF, SPEARMINT OIL 4 fl oz (118 ML) Questions? 1-888-687-4334 Manufactured in the USA distributed by a Service-Disabled Veteran-Owned Family Business Located in Upstate NY Mountainside Medical Equipment Marcy, NY 13403 Label image-01
Principal Display Panel MUSCEL THERAPY GEL MOUNTAIN ICE SPORTS RECOVERY GEL VEGAN GLUTEN FREE \ ǀ / GLUTEN FREE \ ǀ / MADE WITH NATURAL INGREDIENTS MOUNTAIN ICE 3 FL OZ (99 ML) Made in the USA by a Family Owned Service-Disabled Veteran-owned Small Business Mountain Ice 9262 Old River Road Marcy, NY 13403 USA www.Mountain-Ice.com If Pregnant or Breastfeeding: Ask a health professional before use Label image-02
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 the reach of children. If accidentally swallowed, seek medical attention immediately or contact 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 doctor if: Conditions worsen, skin irritation develops, or condition does not improve after 7 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: • Do not apply to wounds, damaged skin, or irritated skin. • Do not apply with other creams, ointments, sprays or liniments.
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. Avoid contact with eyes or mucous membranes. When using this product: • Do not apply to wounds, damaged skin, or irritated skin. • Do not apply with other creams, ointments, sprays or liniments. Stop use and ask a doctor if: Conditions worsen, skin irritation develops, or condition does not improve after 7 days. Keep out the reach of children. If accidentally swallowed, seek medical attention immediately or contact 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