Active Ingredients
Menthol 5.0%
Methyl Salicylate 1.0%
Eagle Brand Patch
FDA Label NDC 43405-300
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 43405-300). 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.
Warnings
For external use only.
When Using This Product
▪ Avoid contact with eyes or on mucous membranes.
▪ Do not apply to wounds or damaged skin.
▪ Do not bandage tightly.
▪ Do not apply wiht external heat, such as heating pad.
▪ Do not use otherwise than as directed.
Stop Use And Ask A Doctor If
▪ Condition worsens.
▪ Symptoms persist for more than 7 days.
▪ Clear up and occur again within a few days, discontinue use of this product and consult a doctor.
▪ Skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occurs.
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 12 years of age and above:
▪ Clean and dry affected area before applying.
▪ Do not leave the patch on skin for more than 8 hours.
▪ Apply to affected area not more than 3 to 4 times daily.
Children under 12 years of age:
▪ Do not use, consult a doctor.
Other Information
▪ Avoid storing product in direct sunlight.
▪ Protect product from excessive moisture.
Inactive Ingredients
Clematis chinensis root, FD&C Blue No.2, Frankincense, Momordica cochinchinensis seed, Myrrh, Pinus massoniana resin, Ricinus communis seed, Sesame oil, Yellow OB, Yellow wax, Zinc oxide
Questions?
If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769.
Package Label
5 Patches Pouch NDC: 43405-300-05
5 Patches Ub (Unitbox)
* Please review the disclaimer below.
