Active Ingredients
Camphor 2.2%
Menthol 14%
Eagle Brand Oil
FDA Label NDC 43405-097
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Borden Company (private) Limited for the product Eagle Brand (NDC 43405-097). 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, if pregnant or breast-feeding, keep out of reach of children, 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 temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains, and itching associated with • insect bites.
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 otherwise than as directed.
Stop Use And Ask A 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.
If Pregnant Or Breast-Feeding
Ask a health professional before use.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Centre right away.
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,clove oil, D&C Red No.17, fragrance,light mineral oil
Questions
If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769.
Package Label
3ml NDC: 43405-097-03
24ml NDC: 43405-097-24
36ml NDC: 43405-097-36
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