Otc - Purpose
| Active ingredient | Purpose |
| Menthol 16% .................... | Topical analgesic |
Flexsport Roll On Liquid
FDA Label NDC 55758-360
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Flexsport Roll On (NDC 55758-360). 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 - 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., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with:
- arthritis
- simple backache
- muscle strains
- sprains
- bruises
Warnings
For external use only. Avoid contact with the eyes.
Flammable: keep away from fire or flame.
When Using This Product
- do not bandage tightly or use with a heating pad
- do not apply to wounds or damaged, broken or irritated skin
Stop Use And Ask A Doctor If
- condition worsens
- redness is present
- irritation develops
- symptoms persist for more than 7 days or clear up and occur again within a few days
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 right away.
Directions
- use only as directed
- adults and children over 12 years: apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: ask a doctor
Other Information
- store at temperatures not exceeding 15°–30°C (59°– 86°F)
- avoid excessive heat and humidity
Inactive Ingredients
acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, capsaicin, glycerin, isopropyl myristate, propylene glycol, trolamine, water
Questions Or Comments?
1-866-359-3478 (M-F) 9 AM – 5 PM EST or www.pharmadel.com
Principal Display Panel
Topical Analgesic Liquid
FlexSport
Pain Relief
ROLL-ON
- Muscle & Joint Pain
- Backaches
- Arthritis
3 fl oz (89 mL)
* Please review the disclaimer below.
