Active Ingredients
Menthol 14.5%
Methyl Salicylate 30%
Eagle Oil
FDA Label NDC 60954-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eagle Indo Pharma for the product Eagle (NDC 60954-008). 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 active ingredients, purpose, uses, warning, do not use, ask a doctor before use if, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Topical Analgesic
Uses
temporarily relieves the minor aches and pains of muscle and joints associated with :
■simple backache ■strains ■bruises ■sprains
Warning
For external use only
Do Not Use
■ on wounds or damaged skin ■ with a heating pad
Ask A Doctor Before Use If
you have redness over affected area
When Using This Product
■avoid contact with eyes or mucous membranes ■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 poisoning. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ Use only as directed ■adults and children 2 years and over: apply to affected area not more than 3 to 4 time daily ■children under 2 years of age: ask a doctor
Inactive Ingredients
D&C Green No. 6, D&C Yellow No. 11, ethyl alcohol, mineral oil, rose oil
Question?
1-800-777-6717 or 1-800-645-0769
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