Instaflex Pain Relief Cream
FDA Label NDC 70015-665

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 Cream (NDC 70015-665). 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 Ingredient

Menthol (1.25%)

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 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. 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

PAIN RELIEVING CREAM  

Instaflex

PAIN RELIEF

Formulated with an 

EXCLUSIVE OXYGENATED OIL 

FAST RELIEF FOR ARTHRITIS,

JOINT & MUSCLE PAIN 

POWERFUL PAIN RELIEF STARTS IN MINUTES,

LASTS FOR HOURS 

Deep Penetrating |  Fast Acting |  Pleasant Smelling |  Non-Greasy 

CLINICALLY STUDIED | DOCTOR DEVELOPED 

Net wt. [2/4] oz ([57/113] g)

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