Active Ingredients
Camphor 11%
Menthol 16%
Paingel Unguento Ointment
FDA Label NDC 85110-116
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 Unguento (NDC 85110-116). 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 active ingredients, purpose, use, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast – feeding, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Use
for temporary local relief of minor pains of muscles and joints associated with simple backache, arthritis, sprains and strains.
Warnings
- For external use only.
- Ask a doctor before use if you have redness over affected area.
When Using This Product
- Use only as directed.
- Do not bandage tightly or use with a heating pad.
- Avoid contact with eyes and mucous membranes.
- Do not apply to wounds or damaged, broken or irritated skin.
- If you experience an allergic reaction, discontinue use and consult a physician.
- 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 injury, such as pain, swelling or blistering where the product was applied.
If Pregnant Or Breast – Feeding
Ask a health professional before use.
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 a 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 Ingredients
Petrolatum, Cera Alba, Mentha Piperita (Peppermint) Oil, Tapioca Starch, Eugenia Caryophyllus Bud Oil, Curcuma Longa (Turmeric) Root Extract, Glycerin, Water (Aqua), Eugenol.
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