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| Product NDC Code | 55319-820 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Family wellness ultra strength muscle rub |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 283083 | ||||||
| Application Number | part348 | ||||||
| Labeler Name | FAMILY DOLLAR (Family Wellness) | ||||||
| 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 Camphor- 4% Menthol - 10% Methyl salicylate -30%
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 Use only as directed 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; ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Carbomer, Disodium ETDA, Glyceryl Sterate SE, Lanolin, Polysorbate 80, Potassium Hydroxide, Stearic Acid, Triethanolamine, Water (purified)
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 temporary relief of minor aches and pains of muscle and joints associated with; simple backaches, arthritis, strains, bruises and sprains
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic Topical Analgesic Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Family Wellness Ultra Strength Muscle Rub Ultra Strength Muscle Rub CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) MENTHOL, UNSPECIFIED FORM MENTHOL METHYL SALICYLATE SALICYLIC ACID CARBOMER 940 EDETATE DISODIUM ANHYDROUS GLYCERYL STEARATE SE LANOLIN POLYSORBATE 80 POTASSIUM HYDROXIDE STEARIC ACID TROLAMINE WATER
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 -Tube Family Wellness 55319-820-57 Ultra Strength Pain Relief Cream Camphor 4%, Menthol 10%, Methyl Salicylate 30% NET WT 2.0 OZ (57g) 254510_FD_UltraPainRelief_Tube
Principal Display Panel - Carton Family Wellness 55319-820-57 Ultra Strength Pain Relief Cream Camphor 4%, Menthol 10%, Methyl Salicylate 30% NET WT 2.0 OZ (57g) 554510_FD_UltraPainRelief_Carton
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 controlled room temperature 20°- 25°C ( 68° to 77°F) Close cap tightly afteruse.
Questions? 1-800-814-8028
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 this and all drugs out of the reach of children. If swallowed, 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 symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive skin irritation occur
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 mucous 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 Do not use on wounds or damaged skin with a heating pad on a child under 12 years of age with arthritis-like condiitions Ask a doctor before use if you have; redness over thre affected area
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