Active Ingredients
Menthol 14.5%
Methyl Salicylate 30.0%
Eagle Brand Oil
FDA Label NDC 60954-018
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pt. Eagle Indo Pharma for the product Eagle Brand (NDC 60954-018). 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, warnings, when using this product, stop use and ask doctor if, keep this drug out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
Temporarily relieves minor muscle and joint pain due to:
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
For external use only
When Using This Product
- use only as directed.
- do not get into eyes or mucous membranes.
- do not apply to wounds or damaged skin.
- do not bandage tightly.
Stop Use And Ask Doctor If
- excessive skin irritation develops.
- pain worsens or does not improve within 7 days, or clears up and appears again in a few days.
Keep This Drug Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily.
- Children under 2 years: ask a doctor.
Inactive Ingredients
Chlorophyll, ethyl alcohol, mineral oil, rose oil
Questions?
Refer questions or to report serious side effects to 1-800-777-6717 or 1-800-645-0769.
Package Label
24ml NDC: 60954-018-24
36ml NDC: 60954-018-36
* Please review the disclaimer below.
