Active Ingredients
Menthol 15%
Camphor 11%
Eagle Balm Ointment
FDA Label NDC 60954-010
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 Balm (NDC 60954-010). 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 a doctor if, keep 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
External Analgesic
External Analgesic
Uses
For the temporary relief of minor pains and aches of muscles and joints associated with ■simple backache ■arthritis ■strains ■bruises ■sprains
Warnings
For External Use Only
When Using This Product
■ Avoid getting itno the eyes or on mucous membranes ■do not apply to wounds or damaged skin ■do not bandage tightly or use with a heating pad ■do not use otherwise than as directed
Stop Use And Ask A Doctor If
■Conditions worsens ■symptoms persist for more than 7 days or clear up and occur again within a few days ■redness is present
Keep Out Of Reach Of Children
In case of accidental ingestion contact a doctor or Poison Control Center immediately.
Directions
■ Adults and children 12 years of age: apply to affected area not more than 3 - 4 times daily. ■children under 12 years of age, consult a doctor before using
Other Information
■ Store in a a cool, dry place
Inactive Ingredients
fragrance, paraffin, peppermint oil, petrolatum
* Please review the disclaimer below.
