Pure Ease Neur Cream Instant Deep Pain Relief Cream
FDA Label NDC 83676-436
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Serenu, Inc. for the product Pure Ease Neur Cream Instant Deep Pain Relief (NDC 83676-436). 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 drug facts, active ingredients, purpose, uses, warning, do not use, when using this product, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Capsaicin 0.025%, Menthol 8.00%
Purpose
Topical Analgesic
Uses
•For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.• Provides cooling pain relief.
Warning
• For external use only
Do Not Use
• On damaged or broken skin.
When Using This Product
• Keep out of eyes. Rines with water to remove • Do not bandage tightly.
Stop Use And Ask A Doctor If:
• Rash or irritation develops and lasts. • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
• Keep Out Of Reach Of Children.
If swallowed, get medical help, or contact a Poison Control Center right away.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Directions
• Adults and children 2 years of age and older : Apply to affected area not more than 3 to 4 times daily. • Children under 2 years of age: consult a doctor.
Other Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deioinzed Water), L-Arginine-Monohydrochloride, HCL, Amica Montana FlowerExtract, Ascorbyl Phosphate (Liposomal Vitamin C), Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cannabis Saliva (Hemp) SeedOil, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cyanocobalamin (Vitamin 12), Emu Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Ilex Paraguariensis (Verba Mate') Extract, Magnesium Sulfate, Methyl Salicylate, Methylsulfonylmethane (MSM), Phenoxyethanol, Phospholipids, Sorbitan Olivate, Stearic Acid, Urea, Xanthan Gum, Zemea (Com) Propanediol, Zingiber Officinalis (Ginger) Extract.
Questions?
302-425-1815
Package Labeling:
Label02 (Label02)
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