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  5. Label Information: Instaflex Extra Strength Pain Relief Cream

FDA Label for Instaflex Extra Strength Pain Relief Cream

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - WHEN USING
    9. OTC - STOP USE
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DOSAGE & ADMINISTRATION
    12. STORAGE AND HANDLING
    13. INACTIVE INGREDIENT
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Instaflex Extra Strength Pain Relief Cream Product Label

The following document was submitted to the FDA by the labeler of this product Healthy Directions, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.