FDA Label for Pain Relieving Roll-on
View Indications, Usage & Precautions
Pain Relieving Roll-on Product Label
The following document was submitted to the FDA by the labeler of this product Safetec Of America, Inc.. 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.
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Drug Facts
Active Ingredients
USP Menthol 7%
Purpose
Topical Analgesic
Uses
Temporary relief of minor aches and pains of muscles and joints.
Warnings
For external use only. Flammable.
Keep Away From Flame. Keep Out Of Reach Of Children.
If swallowed get medical help or contact a poison control center right away. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly.
Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.
Directions
For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.
Other Information
Store at room temperature.
Inactive Ingredients
Eucalyptus Oil, Glycerin, Isopropyl Alcohol, Methyl Salicylate, Purified Water, Tea Tree Oil, Xanthan Gum.
Principal Display Panel - 3 Oz. Bottle Label
Safetec
PAIN RELIEVING
ROLL-ON
FAST-ACTING MUSCLE RELIEF
with Tea Tree & Eucalyptus Oils
Reorder No. 58003
3 fl. oz. (88ml) • Topical Analgesic
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