INSTAFLEX PAIN RELIEF CREAM- menthol 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 Pain Relief Cream

Drug Facts 

Active Ingredient

Menthol (1.25%)

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 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 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 

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)

2oz Tube

2oz Carton

4oz Tube

4oz Carton

INSTAFLEX PAIN RELIEF CREAM 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70015-665
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.5 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:70015-665-021 in 1 CARTON01/01/2019
157 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70015-665-041 in 1 CARTON01/01/2019
2113 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:70015-665-011 in 1 CARTON06/10/2020
328 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 finalpart34801/01/2019
Labeler - Healthy Directions, LLC (150261183)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(70015-665)

Revised: 6/2020
Document Id: a7bfa4b5-72a7-334a-e053-2a95a90aed3d
Set id: 665b847a-9cfb-49fc-975b-81c97f936575
Version: 2
Effective Time: 20200610
 
Healthy Directions, LLC