Active Ingredients
Camphor ………………. 6%
Menthol …………….…. 10%
Paingel Cream
FDA Label NDC 85110-610
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 85110-610). 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, ask a doctor before use if, when using this product, if pregnant of breast feeding, otc - 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
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.
- Use only as directed.
- Do not bandage tightly.
- Do not use with heating pad, pack, wrap, hot water bottle or any heating element.
Ask A Doctor Before Use If
you have redness over affected area.
When Using This Product
- Avoid contact with eyes, mucous membranes, rashes.
- Do not apply to wounds or damaged skin.
- If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product, and consult a doctor.
If Pregnant Of 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 thin layer to the affected area and rub gently not more than 3 to 4 times daily.
- Wash hands with soap and water after use.
Children under 12 years of age. Do not use unless directed by a doctor.
Other Information
Store at room temperature 15° - 30°C (59° - 86°F)
Inactive Ingredient
Water (Aqua), Alcohol Denat, Paraffinum Liquidum, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Glyceryl Stearate, Dimethicone, Caprylic/Capric Triglyceride, Glycerin, Polysorbate 60, Polyacrylamide, Propylene Glycol, Tocopheryl Acetate, Stearyl Alcohol, Polysorbate 20, C13-14 Isoparaffin, Xanthan Gum, Laureth-7, Triethanolamine, Diazolidinyl Urea, Methylparaben, Propylparaben.
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