Label: FLEX24 PERFORMANCE PEN- camphor liquid

  • Category: HUMAN OTC DRUG LABEL

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 8, 2019

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  • Active Ingredient

    Camphor, 7.79%

  • Purpose

    Topical analgesic

  • Uses

    For temporary relief of minor aches and pains of muscle and joints associated with simple arthritis, strains, bruises and sprains

  • Warnings

    For external use only

    Do not

    apply to open wounds, or damaged, broken, or irritated skin

    Stop use and ask a doctor

    if condition worsens or if there is redness or irritation in the applied area or if symptoms persist for more than 7 days or clear up and occur again within a few days

    Caution

    • Discontinue use if excessive irritation of the skin develops
    • Avoid contact with the eyes and mucous membranes
    • Arthritis: If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age consult a physician immediately

    Pregnant or breast feeding

    ask healthcare professional about use

  • Keep out of reach of children

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

  • Directions

    Adults and children over the age of 12:

    • Remove plastic top from device and put aside till after treatment
    • Apply ointment to affected area
    • Repeat if necessary but no more than 3 treatments a day.

    Children under 12, consult a doctor before use.

  • Inactive Ingredients

    Aconitum kusnezoffii root, Angelica dahurica root, Angelica sinesis root, Asarum heterotropoides var. mandshuricum root, Drynaria fortunei root, Eleutherococcus nodiflorus root bark, Ethyl alcohol, Eucalyptus oil, Frosythia suspensa fruit, Frankincense, Gardenia jasminoides fruit, Lavender oil, Lemon, Myrrh, Paeonia suffruticosa root bark, Peppermint oil, Pinellia ternata root, Red paeonia lactiflora root, Rhemannia glutinosa root (raw), Rhubarb, Safflower, Tangerine peel, Turmeric, White paeonia lactiflora root, Wintergreen oil, Zanthoxylum nitidum root, Zeodary

  • Other Information

    Keep sealed in a dry environment at no more than 85°F/29°C and avoid any direct sun exposure

  • Questions/Comments?

    www.larasan.com/performancepen

  • Distributed By:

    Larasan Pharmaceutical Corporation

    401 East Las Olas Blvd., Suite 1400

    Ft. Lauderdale, FL 33301

    Tel. 1-855-LARASAN

    NDC 54641-004-02

    Made in China

  • Flex24™ Performance Pen

    Topical Analgesic

    Aches Pains Bruises Sprains

    0.34 fl. oz. (10 mL)

    20140610 Flex24 Perf Pen

  • INGREDIENTS AND APPEARANCE
    FLEX24 PERFORMANCE PEN 
    camphor liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54641-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)7.79 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    ACONITUM KUSNEZOFFII ROOT (UNII: 3L29I4K8KX)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    ASARUM HETEROTROPOIDES VAR. MANDSHURICUM ROOT (UNII: HK49KSK8L3)  
    DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)  
    ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB)  
    ALCOHOL (UNII: 3K9958V90M)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FORSYTHIA SUSPENSA FRUIT (UNII: P4793M1ES5)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LEMON (UNII: 24RS0A988O)  
    MYRRH (UNII: JC71GJ1F3L)  
    PAEONIA SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PINELLIA TERNATA ROOT (UNII: G9AET085M5)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
    RHUBARB (UNII: G280W4MW6E)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    TANGERINE PEEL (UNII: JU3D414057)  
    TURMERIC (UNII: 856YO1Z64F)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    ZANTHOXYLUM NITIDUM ROOT (UNII: L2CQZ81759)  
    ZEDOARY (UNII: 123C43G128)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54641-004-0210 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product04/08/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/08/2014
    Labeler - Larasan Pharmaceutical Corporation (078350375)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dong E E Hua Medical Technology Co Ltd527813247manufacture(54641-004)
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