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| Product NDC Code | 45802-174 | ||||
|---|---|---|---|---|---|
| Drug Name | Muscle rub |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 311498 | ||||
| Application Number | part348 | ||||
| Labeler Name | Padagis Israel Pharmaceuticals Ltd | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Menthol 10% Methyl salicylate 15%
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 & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 12 years of age: consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, glyceryl monostearate, lanolin, methylparaben, propylene glycol, propylparaben, purified water, stearic acid, trolamine
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 temporarily relieves the minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • 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.Muscle Rub Menthol, Methyl salicylate MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM METHYL SALICYLATE SALICYLIC ACID CITRIC ACID MONOHYDRATE GLYCERYL MONOSTEARATE LANOLIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER STEARIC ACID TROLAMINE
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 Deep Penetrating Pain Relief Fast Relief from Minor Arthritis, Backache, Muscle & Joint Pain Compare to Bengay ® active ingredients Muscle Rub Greaseless Pain Relieving Cream NET WT 3 OZ (85 g) Muscle Rub Image 1 Muscle Rub Image 2
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 • other than as directed • on children under 12 years of age • with a heating pad (may blister 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 to avoid accidental poisoning. 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 or comments? 1-800-719-9260
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 • skin redness or excessive irritation of the skin develops • condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur 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 or mucous membranes • do not apply to wounds or damaged skin • do not bandage tightly
Storage and handling
Information about safe storage and handling of the drug product.Other information • store at 20°-25°C (68°-77°F) • Lot No. & Exp. Date, see crimp of tube and see box
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 • other than as directed • on children under 12 years of age • with a heating pad (may blister skin) When using this product • avoid contact with the eyes or mucous membranes • do not apply to wounds or damaged skin • do not bandage tightly Stop use and ask a doctor if • skin redness or excessive irritation of the skin develops • condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a 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