Otc - Active Ingredient
Menthol 7%
Methyl Salicylate 20%
Paingel Spray
FDA Label NDC 85110-207
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 (NDC 85110-207). 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, use, warnings, flammable, otc - when using, stop use and ask a doctor if, if pregnant or breast – feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
External Analgesic
Use
For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
Warnings
- For external use only.
- Do not apply to wounds or damaged skin, with a heating pad or on a child under 12 years of age.
Flammable
Keep away from fire or flame.
Otc - When Using
- Use only as directed.
- Do not bandage tightly.
- Avoid contact with eyes and mucous membranes.
- If you experience an allergic reaction, discontinue use, and consult a doctor.
- Do not expose the area treated with product to heat or direct sunlight.
Stop Use And Ask A Doctor If
- Condition worsens.
- Redness is present.
- Irritation develops.
- Symptoms persist for more than 7 days or clear up occur again within a few days.
- You experience signs of injury, such as pain, swelling or blistering where the product was applied.
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
Spray two to three pumps or as necessary to cover the affected area not more than three to four 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
Alcohol Denat, Water (Aqua), Glycerin, Propylene Glycol, Aloe Barbadensis (Aloe Vera) Leaf Juice.
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