Active Ingredients
Capsaicin, 0.10%
Cannavera Pain Relief
FDA Label NDC 80295-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Leading Edge Pharms, Inc. for the product Cannavera Pain Relief (NDC 80295-100). 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, uses, warnings, if pregnant or breastfeeding, 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
Purpose
External Analgesic
Uses
For temporary relief of minor aches and pains of muscles and joints due to:
• simple backache • arthritis • strains • bruises • sprains
Warnings
For external use only.
Read all warnings and directions before use.
Test first on small area of skin.
If Pregnant Or Breastfeeding
• Ask a health professional before use.
• CA AB-45: the FDA strongly advises against the use of cannabis, including CBD, in any form, during pregnancy or while breastfeeding.
Do Not Use.
• If you are allergic to any ingredients of this product
When Using This Product
• You may experience a burning sensation that generally disappears after several days of regular use. The intensity of this reaction varies among individuals and may be severe.
• Avoid contact with the eyes or mucous membranes. • Do not bandage tightly or use with a heating pad.
Stop Use And Ask A Doctor If
• Condition worsens or does not improve after regular use. • Severe burning persists or blistering occurs.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Adults and children 18 years of age or older
• Apply a thin film of oil to affected area and gently rub in until fully absorbed • Wash hands with soap and water after use • Apply to affected area not more than 3 to 4 times daily.
Children under 18 yearsask a doctor
Other Information
• Store at 15° - 30°C (59° - 86°F)
Inactive Ingredients
Capric Triglycerides, Grape Seed Oil, Rosehip Oil, Passion Fruit Seed Oil, Eucalyptus Leaf Oil, Propanediol, Ethanol SDA 3A, Hemp (Cannabis sativa L.) Leaf Extract, hosphatidylcholine, Aloe Barbadensis Leaf Powder, Sage Leaf Extract, Arnica Leaf Extract, Rosemary Leaf Extract, Bergamot Fruit Oil, Sweet Almond Oil, Tocopherol Acetate, C12-15 Alkyl Benzoate, Lavender Oil, Chamomile Flower Extract, Capryl Glycol, Hexylene Glycol, Phenoxyethanol, Ethylhexylglycerin, Ascorbyl Palmitate, Ascorbic Acid Tocopherol Acetate, Citric Acid.
Questions?
Call 1-888-536-2872
Package Labeling:
Label (Label)
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