FDA Label for Eagle Brand Medicated Oil Aromatic
View Indications, Usage & Precautions
Eagle Brand Medicated Oil Aromatic Product Label
The following document was submitted to the FDA by the labeler of this product Pt. Eagle Indo Pharma. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
- Camphor 7%
- Menthol 16%
- Methyl Salicylate 35%
Purpose
External Analgesic
Uses
For temporary relief of minor aches and pain 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 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 Centre 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 oF (30 oC).
Inactive Ingredients
eucalyptus oil, light mineral oil, lavender spike 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
24ml NDC: 60954-014-24
36ml NDC: 60954-014-36
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