Active Ingredient
Menthol 4.0% w/w ...... Purpose: Topical Analgesic
Pain Relief Gel-roll On
FDA Label NDC 83016-331
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by R & Y Group, Llc for the product Pain Relief Gel-roll On (NDC 83016-331). 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 ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, 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
Topical Analgesic
Uses
■ For temporary relief of minor aches and pains of muscles and joints
Warnings
For External Use Only
Flammable: Keep away from excessive heat or open flame
Ask a doctor before use if you have: Sensitive skin
When Using This Product
■ Avoid contact with eyes or mucous membranes ■ Do not apply to wounds or damaged skin ■ Do not use with other ointments, creams, sprays or liniments ■ Do not apply to irritated skin or if excessive irritation develops ■ Do not bandage ■ Wash hands after use with cool water ■ Do not use with heating pad or device ■ Store in a cool dry place
Stop Use And Ask A Doctor If
condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur
If Pregnant Or Breast-Feeding
ask a health professional before use
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
■ Adults and children 12 years of age and older:
Rub a thin film over affected areas not more than 4 times daily; massage not necessary
■ Children under 12 years of age: Consult Physician
Inactive Ingredients
Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water
Otc - Questions
www.theraice.com
Package Label.Principal Display Panel
Bottle label:
Bottle Label (83016 331 01)
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Bag (1 bottle) label:
Bag Label (83016 331 11)
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Bag (3 bottles) label:
21 (83016 331 21)
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