Instaflex Extra Strength Pain Relief Cream
FDA Label NDC 70015-660

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 Extra Strength Pain Relief Cream (NDC 70015-660). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts 

Otc - Active Ingredient

Active Ingredients

Menthol (2.5%)

Methyl Salicylate (10%) 

Otc - Purpose

Purpose

Topical Analgesic 

Indications & Usage

Uses Temporarily relieves minor aches and pains of muscles

and joints associated with: 

  • simple backache
  • arthritis 
  • strains 
  • sprains 
  • bruises

Warnings

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. 

Dosage & Administration

Directions Adults 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. 

Storage And Handling

Other Information Keep product at room termperature and

humidity [59-86°F (15-30°C), 40% RH]. Do not freeze. For Lot

Number and Expiration Date, see crimp at end of tube. 

Inactive Ingredient

Inactive ingredients C13-14 Isoparaffin, Citrus Aurantium

Dulcis (Orange) Oil, Ethylhexlglycerin, Eucalyptus Globulus Oil,

Glyceryl Stearate, Laureth-7, Oxygenated Corn Oil, PEG-100

Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Water 

Package Label.Principal Display Panel

EXTRA STRENGTH PAIN RELIEVING CREAM

Instaflex 

PAIN RELIEF

Formulated with an 

EXCLUSIVE OXYGENATED OIL 

FAST, EXTRA STRENGTH RELIEF FOR

ARTHRITIS, JOINT & MUSCLE PAIN 

DOUBLE THE PAIN-FIGHTING INGREDIENTS

DOUBLE THE MENTHOL POWER*

Deep Penetrating |  Fast Acting |  Great for Nighttime Use 

EXTRA STRENGTH | DOCTOR DEVELOPED 

Net wt. [2/4] oz ([57/113] g) 

* Please review the disclaimer below.