Label: INSTAFLEX EXTRA STRENGTH PAIN RELIEF CREAM- menthol, methyl salicylate 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 January 11, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts 

  • ACTIVE INGREDIENT

    Active Ingredients

    Menthol (2.5%)

    Methyl Salicylate (10%) 

  • 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 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 

  • 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) 

    2oz Carton

    2oz Tube

    4oz Carton

    4oz Tube

  • INGREDIENTS AND APPEARANCE
    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)
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