Active Ingredients
Menthol 14%
Methyl Salicylate 15%
Eagle Medicated Oil
FDA Label NDC 60954-005
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, Pt for the product Eagle Medicated Oil (NDC 60954-005). 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 muscles and joints associated with ■simple backache ■strains ■bruises ■ sprains
Warning
For external use only
Do Not Use
■ on wounds or damaged skin ■ with a heatng pad
Ask A Doctor Before Use If
you have readness over affected area
When Using This Product
■ avoid contact with eyes or on 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 of age and older: apply to affected area not more than 3 to 4 times daily. ■ children under 2 years of age: ask a doctor
Inactive Ingredients
clove oil, eucalyptus oil, fragrance, light mineral oil
Question?
1-800-777-6717 or 1-800-645-0769
* Please review the disclaimer below.
