El Balsamo De Tigre Ointment
FDA Label NDC 79974-208
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Miramar Cosmetics, Inc Dba Miramar Lab for the product El Balsamo De Tigre (NDC 79974-208). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses:, warnings:, otc - keep out of reach of children, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Methyl Salicylate 10%
Menthol 3.5%
Purpose
Topical Analgesic
Uses:
*Helps relieve minor aches and pain of muscles, joints, strains, backache, sprains, and sport injuries.
Warnings:
For external use only.
Do not Use:
• If allergic to salicylates (including aspirin) without consulting a physician.
• On open wounds, damage or irritated skin, immediately after or before taking a shower.
Stop use and ask a Doctor: If conditions worsen, symptoms persist or skin irritations occurs.
When using this product: Avoid contact with eyes, lips and any mucous membranes.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed get medical help. Do not bandage.
Directions:
Clean area before use.
Adults & Children 12 years of age or older: Apply to affected area no more than 3 times daily. Temporary burning may be felt when applied, but disappears with continued use.
Wash hands after used. If applying liniment to the hands wait 30 minutes before washing hands. Initial pain relief is noted within 1-2 weeks.
Children under 12 years: Consult a Physician before use.
Other Information:
Store at 15-25° C (59-77° F)
Inactive Ingredients:
White Petrolatum, Eucalyptus oil, Clove Oil, Dark Brown MX-486
Packaging
Miramar-208 (7997420805)
* Please review the disclaimer below.
