Active Ingredients
- Camphor 4%
- Menthol 15.5%
Eagle Brand Ointment
FDA Label NDC 60954-201
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 60954-201). 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 out of reach of children, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains.
Warnings
For external use only
When Using This Product
- Avoid getting into the eyes or on mucous membranes.
- Do not apply to wounds or damaged skin.
- Do not bandage tightly.
- Do not use if excessive irritation of the skin develops.
- Do not use otherwise than as directed.
Stop Use And Ask Doctor If
Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breast-Feeding
Ask a health professional before use.
Directions
• 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: do not use, consult a doctor.
Other Information
Store below 86°F (30°C ).
Inactive Ingredients
Beta carotene, D&C Green No.6, fragrance, paraffin, petrolatum
Questions?
If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769.
Package Label
20g NDC: 60954-201-20
* Please review the disclaimer below.
