Otc - Active Ingredient
Active ingredient:
Menthol 3.70%
Joint And Muscle Relief Cream
FDA Label NDC 87282-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Smart Cookie Solutions Inc. for the product Joint And Muscle Relief (NDC 87282-001). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, 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
Otc - Purpose
Purpose
Topical Analgesic
Indications & Usage
Uses
For the temporary relief of minor aches and pains of muscles and joints.
Warnings
Warnings: For external use only
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product • Avoid contact with the eyes. • Do not bandage tightly.
Otc - Stop Use
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contacct a Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Dosage & Administration
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 Ingredient
Inactive ingredients: aloe barbadensis leaf juice, arnica montana extract, caprylyl glycol, carbomer, dimethyl sulfone, disodium EDTA, glycerin, glyceryl laurate, glyceryl undecylenate, ilex paraguariensis leaf extract, isopropyl alcohol, melaleuca alternifolia (tea tree) leaf oil, polysorbate 20, pyridoxine HCl, tocopheryl acetate, triethanolamine, water(aqua).
Otc - Questions
Questions?
904-439-7618
Other
Made in USA
Dist. by: Smart Cookie Solutions Inc. 10685-B Hazelhurst Dr. #18381, Houston, TX 77043
Package Label.Principal Display Panel
Joint & Muscle Relief
Cream
Topical Analgesic Cream
• Arnica Extract • Ilex Extract
• Aqua • Tea Tree
• Aloe Leaf Juice
3 fl oz (89ml)
* Please review the disclaimer below.
