Label: INSTAFLEX PAIN RELIEF CREAM- menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated June 10, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts 

  • ACTIVE INGREDIENT

    Active Ingredient

    Menthol (1.25%)

  • 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

    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. 

  • 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 

  • 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)

    2oz Tube

    2oz Carton

    4oz Tube

    4oz Carton

  • INGREDIENTS AND APPEARANCE
    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)
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