Otc - Active Ingredient
Menthol ………………………………...…………………………….…. 3%
Paingel Roll-on Gel
FDA Label NDC 85110-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nacor Business Group Llc for the product Paingel Roll-on (NDC 85110-003). 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 otc - active ingredient, otc - purpose, uses, warnings, otc - when using, if pregnant or breast-feeding, otc - 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
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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