Drug Facts
Menthol - 5% (External Analgesic)
Methyl Salicylate (NSAID) – 7.5% (External Analgesic)
Happy Elf Hemp Pain Relief Cream
FDA Label NDC 73658-3401
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Happy Elf Cbd Corporation for the product Happy Elf Hemp Pain Relief Cream (NDC 73658-3401). 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, uses:, warnings:, otc - keep out of reach of children, otc - do not use, otc - ask doctor, otc - when using, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses:
For temporary relief of minor aches and pains of muscles and joints associated with backache, muscle ache, strains, sprains, bruises, cramps, arthritis, and inflammation
Warnings:
External Use Only!
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Otc - Do Not Use
Do not use:
• on wounds or damaged skin
• with a heating pad
• on a child under 12 years of age with arthritis-like conditions
Otc - Ask Doctor
Ask a doctor before use if you have redness over the affected area.
If pregnant or breast-feeding, or if you have sensitive skin, ask your doctor before use
Avoid contact with eyes. If contact occurs, flush thoroughly with water.
Otc - When Using
When using this product:
• avoid contact with eyes or mucous membranes
• do not bandage tightly
Indications & Usage
Stop use and ask a doctor if: condition worsens or symptoms persist for more than 7 days, symptoms clear up and occur again within a few days, excessive skin irritation occurs
Directions:
Use only as directed. Apply generously and massage to affected area as needed. Do not use more than 3 to 4 times per day.
Children under 12 years of age: ask a doctor before use.
Inactive Ingredients:
Alpha-Tocopherol Acetate (Vitamin E), Aminomethylpropanol, Arnica Montana Flower, Hemp Oil, Carbomer, Cetostearyl Alcohol, Dimethyl Sulfone, Dimethyl Sulfoxide, Ethylhexyl Palmitate, Ethylhexylglycerin, Glucosamine, Glyceryl Monostearate, Magnesium Hydroxide, Phenoxyethanol, Polysorbate 80, Water
Other Information:
Store at room temperature 68°F to 77°F (20° to 25°C)
Do not expose to excessive heat
Allergy Alert:
Do not use if you are allergic to salicylates (including aspirin) without consulting a physician.
For Questions
Call +1 (239) 236-8158
Happy Elf CBD Corporation
2250 NW 102 PL
Miami, FL 33172
Website: www.happyelf.com.com
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