Label: FLEX24 PAIN 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, cramps, 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.

  • 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 liniment to affected area

    • Repeat as necessary but no more than 3 treatments per day

    • Children under 12, consult a doctor before use.

  • Other Information

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

  • Inactive Ingredients

    Aconitum Kusnezoffii Root, Angelica Dahurica Root, Angelica Sinesis Root, Asarum Heterotropoides var. 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, Rehmannia Glutinosa Root (Raw), Rhubarb, Safflower, Tangerine Peel, Turmeric, White Paeonia Lactiflora Root, Wintergreen Oil, Zanthoxylum Nitidum Root, Zeodary

  • Questions/Comments?

    www.larasan.com/painpen

  • Flex24™ Pain Pen

    Powerful Pain Relief

    Distributed by: Larasan Pharmaceutical Corporation, 401 East Las Olas Blvd., Suite 1400, Ft. Lauderdale, FL 33301

    Tel. 1-855-LARASAN

    NDC 54641-003-02

    Made in Chinda

    Lot No.:

    Expiry Date:

    Larasan

    Nature Bioscience Health

    © Larasan Pharmaceutical 2014

  • Flex24™ Pain Pen

    Powerful Pain Relief

    Aches Pains Bruises Sprains

    Topical Analgesic

    0.61 fl. oz. (18 mL)

    20150210 Flex24 Pain Pen

  • INGREDIENTS AND APPEARANCE
    FLEX24 PAIN PEN 
    camphor liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54641-003
    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
    ACONITUM KUSNEZOFFII ROOT (UNII: 3L29I4K8KX)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    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:54641-003-0218 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product02/10/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/10/2015
    Labeler - Larasan Pharmaceutical Corporation (078350375)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dong E E Hua Medical Technology Co Ltd527813247manufacture(54641-003)
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