Label: INSTAFLEX PAIN RELIEF- menthol, methyl salicylate spray

  • 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 December 11, 2019

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  • Drug Facts

  • Active Ingredients

    Menthol (5%)

    Methyl Salicylate (10%)

  • Purpose

    Menthol (5%)....................Topical Analgesic

    Methyl Salicylate (10%)....................Topical Analgesic

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints associated with

    • simple backache
    • arthritis
    • strains
    • sprains
    • bruises
  • Warnings

    For external use only

    Flammable

    Flammable

    • do not use near heat or flame or while smoking
    • avoid long term storage above 104F (40C)
    • do not puncture or incinerate
    • contents under pressure
    • do not store at temperature above 120F (49C)

    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 and mucous membrane
    • avoid inhalation of fumes
    • spray away from face
    • 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: Shake and apply liberally at least 4 inches away from affected area no more than 3-4 times daily. Let dry or rub in for greater efficacy.

    Children under 12 years of age: Consult a doctor.

  • Other information

    Do not freeze. For Lot Number and Expiration Date, see bottom of can.

  • Inactive ingredients

    Citrus Aurantium Dulcis (Orange) Oil, Ethylhexylglycerin, Eucalyptus Globulus Oil, Methylsulfonylmethane (MSM), Oxidized Corn Oil, Phenoxyethanol, SD-Alcohol 40B.

  • PRINCIPAL DISPLAY PANEL

    EXTRA STRENGTH

    PAIN RELIEVING SPRAY

    Instaflex

    PAIN RELIEF

    Formualted with an Exclusive Oxygenated Oil

    Powerful, EXTRA STRENGTH, doctor-developed relief for arthritis, joint & muscle pain

    • Deep Penetrating
    • Fast Acting
    • Quick Drying
    • 360 Continuous Spray

    EXTRA STRENGTH

    PAIN RELIEVING SPRAY

    Net wt. 4.0 oz (113 g)

    AH_IPRESS_4oz_CARTON

  • INGREDIENTS AND APPEARANCE
    INSTAFLEX PAIN RELIEF 
    menthol, methyl salicylate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70015-675
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CORN OIL (UNII: 8470G57WFM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70015-675-401 in 1 CARTON12/11/2019
    1113 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/11/2019
    Labeler - Healthy Directions, LLC (150261183)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(70015-675)
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