FDA Label for Paingel Roll-on
View Indications, Usage & Precautions
Paingel Roll-on Product Label
The following document was submitted to the FDA by the labeler of this product Nacor Business Group Llc. 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.
Otc - Active Ingredient
Menthol ………………………………...…………………………….…. 3%
Otc - Purpose
Topical Analgesic
Uses
For temporary relief of minor aches and pains in muscles and joints.
Warnings
• For external use only.
• Ask a doctor before use if you have redness over affected area.
Otc - When Using
• Avoid contact with the eyes or mucous membranes.
• Do not apply to wounds or damaged skin.
• Do not apply to the irritated skin or if excessive irritation develops.
• Do not bandage tightly.
• Do not use with heating pad or device.
• 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.
If Pregnant Or Breast-Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children over 12 years of age
• Apply a small amount on the affected area.
• Massage in circular motion, let set for a few seconds.
• Repeat as necessary, but no more than 3 to 4 times daily.
Children under 12 years of age. Do not use, consult a doctor.
Other Information
Store tightly closed in a dry place at controlled room temperature between 59°F-86° F(15°C-30° C).
Inactive Ingredient
Water (Aqua), Alcohol Denat, Propylene Glycol, Polysorbate 20, Glycerin, Arnica Montana Flower Extract, Polyacrylamide, C13-14 Isoparaffin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Laureth-7, Sodium Hydroxide, Disodium EDTA, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, FD&C Yellow No.6 (CI 15985).
Questions Or Comments?
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Paingel Roll-On
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