Active Ingredient
Menthol 5%
Pain Relief Gel Roll On Gel
FDA Label NDC 69396-184
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa for the product Pain Relief Gel Roll On (NDC 69396-184). 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, warnings, keep out of reach of children, if pregnant or breast feeding, directions, indications and use, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Warnings
For external use only.
Flammable Keep away from excessive heat or open flames.
Keep Out Of Reach Of Children
If Swallowed, get medical help or contact a Poison Control Center right away
If Pregnant Or Breast Feeding
If Pregnant or breast feeding as a doctor before use.
Directions
- Adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily.
- Children under 2 years of age: ask a doctor
- Wash hands after use with cold water.
Indications And Use
Temporarily relieves minor aches and pains of muscles and joints associated with
- simple backache
- arthritis
- strains
- bruises
- sprains
Other Information
- Store at 20° to 25°C (68° to 77°F)
- Store in cool dry place away from direct sunlight
Inactive Ingredient:
Alcohol, Aloe Vera extract, Arnica Montana Flower extract, Boswellia carteril resin extract, Camellia sinesis leaf extract, Camphor, Carbomer, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex parguariensis leaf extract, Isopropyl myristate, Silica, Triethanolamine, Vitamin E, Water.
Stop Use And Ask Doctor If
Stop use and ask doctor if
- you experience pain, swelling or blistering of the skin
- if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
- arthritic pain persists for more than 10 days or redness is present, or in conditions affecting children under 12 years of age.
Questions?
Call 1-888-296-9067
Distributed By:
Trifecta Pharmaceuticals USA ®
101 NE Third Avenue, Suite 1500
Fort Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
SKU: 4091-FBA
Package Label.Principal Display Panel
409103-globe-menthol-roll-on-3pk-cder (409103 Globe Menthol Roll On 3pk Cder)
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