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| Product NDC Code | 50382-015 | ||||
|---|---|---|---|---|---|
| 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 | Galentic Pharma (India) Private Limited | ||||
| 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 INGREDIENT 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 Use only as directed Adults and 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: ask a doctor
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, Polysorbate 80, 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, UNSPECIFIED FORM and Methyl Salicylate CITRIC ACID MONOHYDRATE GLYCERYL MONOSTEARATE METHYLPARABEN PROPYLPARABEN PROPYLENE GLYCOL POLYSORBATE 80 WATER STEARIC ACID TROLAMINE LANOLIN MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM METHYL SALICYLATE SALICYLIC ACID
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 - 85 g Tube Carton Galentic Muscle Rub ULTRA STRENGTH Pain Relieving Cream Non-Greasy NET WT. 3 OZ. (85g) PRINCIPAL DISPLAY PANEL - 85 g Tube 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.Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone, Gandhidham-370 230, Gujarat. India
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 redness over the affected area
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 On wounds or damaged skin With a heating pad On a child under 12 years of age with arthritis-like conditions
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 Keep out of reach of children to avoid accidental ingestion. 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 occurs
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 or mucous membrane Do not bandage tightly
Storage and handling
Information about safe storage and handling of the drug product.• OTHER INFORMATION Store at 15° to 25 °C (59° to 77°F) Lot No. & Exp. Date : See box or see crimp of tube
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 conditions Ask a doctor before use if you have redness over the affected area When using this product Avoid contact with eyes or mucous membrane Do not bandage tightly 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 occurs • KEEP OUT OF REACH OF CHILDREN Keep out of reach of children to avoid accidental ingestion. If swallowed, 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