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| Product NDC Code | 41250-864 | ||||
|---|---|---|---|---|---|
| Drug Name | Meijer cold therapy pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 415974 | ||||
| Application Number | part348 | ||||
| Labeler Name | Meijer Distribution, Inc. | ||||
| 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 4% Purpose Cooling Pain Relief
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 four 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 Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water, Yellow 5
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 and joints associated with • arthritis • backache • strains • sprains
Purpose
Information about the drug product’s indications for use.Purpose Cooling Pain Relief
Spl product data elements
Usually a list of ingredients in a drug product.Meijer Cold Therapy Pain Relief MENTHOL ALOE VERA LEAF ARCTIUM LAPPA ROOT ARNICA MONTANA FLOWER FD&C BLUE NO. 1 CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF CARBOXYPOLYMETHYLENE GLYCERIN ILEX PARAGUARIENSIS LEAF ISOPROPYL ALCOHOL ISOPROPYL MYRISTATE MELISSA OFFICINALIS LEAF SILICON DIOXIDE TROLAMINE WATER FD&C YELLOW NO. 5 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
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
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 • with heating pad or device • Store in cool dry place.
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.
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 irritattion develops • Do not bandage • Wash hands after use with cool water
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. 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 irritattion develops • Do not bandage • Wash hands after use with cool water Do not use • with heating pad or device • Store in cool dry place. 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