Active Ingredient
Camphor 4.35%
Menthol 2.61%
Eucamint Ointment
FDA Label NDC 10578-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Indiana Botanic Gardens for the product Eucamint (NDC 10578-001). 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 ingredient, 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
topical analgesic
topical antitussive
Uses
Temporary relief of minor aches and pains of muscles & joints associated with simple backache, arthritis, bruises, sprains
Provides cooling pain relief
Temporarily alleviates and suppresses cough due to minor throat & bronchial irritation associated with a cold or inhaled irritant.
Warnings:
For external use only
When Using This Product
Do not heat
Do not microwave
Do not add to hot water or any container when heating water. May cause splattering and result in burns.
Avoid contact with eyes
Do not apply to wounds or damaged skin
Do not bandage tightly
Do not take by mouth or place in nostrils
Do not take or give this product for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucous) unless directed by a doctor.
Stop Use And Ask A Doctor If
muscle aches and pains worsen, or if symptoms persist for more than 7 days or clear up and occur again within a few days
cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
See the important warnings under "when using this product"
Adults and children 2 years of age and older:
Rub on the neck and chest as a thick layer or rub on sore aching muscles.
Cover with a warm, dry cloth if desired.
Clothing should be loose about the neck and chest to help vapors reach the breathing passages.
Use up to three times daily or as directed by a doctor.
Children under 2 years of age: consult physician.
Other Information:
Use only if seal is unbroken.
Inactive Ingredients
Citronella oil, eucalyptus oil, peppermint oil, yellow petrolatum
Questions?
1-800-644-8327
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