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  5. Label Information: Instaflex Pain Relief Cream

FDA Label for Instaflex 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. OTHER INFORMATION
    13. INACTIVE INGREDIENT
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Instaflex Pain Relief Cream Product Label

The following document was submitted to the FDA by the labeler of this product Adaptive Health, 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 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 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. 


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 

Proud Partner of the 

Arthritis

Foundation 

POWEFUL 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) 


* Please review the disclaimer below.