INSTAFLEX EXTRA STRENGTH PAIN RELIEF CREAM- menthol, methyl salicylate cream 
Healthy Directions, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Instaflex Extra Strength Pain Relief Cream

Drug Facts 

Active Ingredients

Menthol (2.5%)

Methyl Salicylate (10%) 

Purpose

Topical Analgesic 

Uses Temporarily relieves minor aches and pains of muscles

and joints associated with: 

Warnings

For external use only

Do not use

  • with a heating pad, may blister skin
  • on open wounds or damaged skin 

Ask a doctor before use if you have

redness over the affected area

When using this product

  • Use only as directed 
  • avoid contact with eyes 
  • do not bandage tightly

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 

Keep out of reach of children. 

If swallowed, get medical help or contact a Poison Control Center right away. 

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 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 

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) 

2oz Carton

2oz Tube

4oz Carton

4oz Tube

INSTAFLEX EXTRA STRENGTH PAIN RELIEF CREAM 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70015-660
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL25 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
ORANGE OIL (UNII: AKN3KSD11B)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LAURETH-7 (UNII: Z95S6G8201)  
CORN OIL (UNII: 8470G57WFM)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70015-660-021 in 1 CARTON03/01/2019
157 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70015-660-041 in 1 CARTON03/01/2019
2113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2019
Labeler - Healthy Directions, LLC (150261183)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(70015-660)

Revised: 1/2019
Document Id: c9ed1379-a1b8-4c7b-bb93-1486b1d91cbe
Set id: d058c64d-0e4f-45aa-8f52-804961b562e3
Version: 1
Effective Time: 20190111
 
Healthy Directions, LLC