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  5. Label Information: Methyl Salicylate 25% Cream

FDA Label for Methyl Salicylate 25% Cream

View Indications, Usage & Precautions

Table of Contents

    1. ​
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF THE REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL

Methyl Salicylate 25% Cream Product Label

The following document was submitted to the FDA by the labeler of this product Medcore Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts


Active Ingredient



Methyl Salicylate 25%


Purpose



Topical analgesic


Uses



For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.


Warnings



​For external use only.


When Using This Product



  • -Avoid contact with the eyes
  • -Do not use in larger quantities, particularly over raw surfaces or blistered areas
  • -Do not apply to wounds or damaged skin
  • -Do not bandage

Stop Use And Ask A Doctor If



  • -allergic reaction occurs
  • -condition worsens or does not improve within 7 days
  • -symptoms clear up and return within a few days
  • -redness, irritation, swelling, pain or other symptoms begin or increase

Keep Out Of The Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away


Directions



adults and children 2 years and olderapply externally to the affected area up to 3 to 4 times a day
children under 2 yearsask a doctor

Other Information



  • -May be applied under occlusive dressing.
  • -Store at 20-25-C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

Inactive Ingredients



Glycerine, CETOSTEARYLALCOHOL, ETHYLHEXYLGLYCERIN, GLUCOSAMINE SULFATE, CHONDROITIN SULFATE, (BOVINE), GLYCERYL MONOSTEARATE, C13-14ISOPARAFFIN, ISOSTEARYL PALMITATE, TROLAMINE, STEARIC ACID, PROPYLENE GLYCOL, LAURETH-7, PEG-100 STEARATE, Water, PHENOXYETHANOL.

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269


Principal Display Panel



NDC: 82461-415-10

Medcore LLC

Methyl Salicylate 25% Cream

120mL

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

Label - methyl salicylate cream 01

Label - methyl salicylate cream 01


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