Active Ingredient
Menthol (1.25%)
Instaflex Pain Relief Roll-on
FDA Label NDC 70015-670
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Healthy Directions, Llc for the product Instaflex Pain Relief Roll-on (NDC 70015-670). 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, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Menthol (1.25%)....................Topical Analgesic
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with
- arthritis
- strains
- sprains
- bruises
Warnings
For external use only
Otc - Do Not Use
Do not use
- with a heating pad, may blister skin
- on open wounds or damaged skin
Otc - Ask Doctor
Ask a doctor before use if you have redness over the affected area
Otc - When Using
When using this product
- Use only as directed
- avoid contact with eyes
- do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if
- skin redness or excessive skin irritation develops
- condition worsens or symptoms persist for more than 7 days
- symptoms clear up and occur again in a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adult and children 12 years of age and older: Apply to affected area no more than 3-4 times daily.
Children under 12 years of age: Consult a doctor.
Other Information
Keep product at room termperature and humidity [59-86°F (15-30°C), 40% RH]. Do not freeze. Lot Number and Expiration Date printed below.
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetyl Alcohol, Citrus Aurantium Dulcis (Orange) Oil, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Oil, Clyceryl Stearate SE, Oxygenated Corn Oil, Phenoxyethanol, Polysorbate-20, Sodium Hydroxide, Steareth-20, Water, Xanthan Gum, Zemea (Corn) Propanediol
Package Label.Principal Display Panel
DOCTOR DEVELOPED
FAST ACTING
PAIN RELIEVING ROLL-ON
Instaflex
PAIN RELIEF
Formualted with an Exclusive Oxygenated Oil
Powerful roll-on relief for arthritis, joint & muscle pain
- Deep Penetrating
- Fast Acting
- Pleasant Smelling
- Non-Greasy
- No Mess
Net wt. 2.5 oz (71 g)
Instaflex (Instaflex)
* Please review the disclaimer below.
