Label: FLEX24 PAIN PEN- camphor liquid

  • 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 August 28, 2019

If you are a consumer or patient please visit this version.

  • 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

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Adults and children 2 years of age and older:

    • Remove plastic top from device and put aside till after treatment

    • Squeeze device if necessary and apply ointment to the affected area

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

    Children under 2 years of age, consult a physician.

  • 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

  • SPL UNCLASSIFIED SECTION

    FLEX24®

    RECOVER NATURALLY

    Dist: FLEX24, INC.

            4020 Galt Ocean Mile, Ste. 1607

            Ft. Lauderdale, FL 33308

            Tel.: 844.4.FLEX24

    Formulated in USA

    Made in China

  • PRINCIPAL DISPLAY PANEL

    ROLL-ON PEN

    PAIN RELIEF

    WORKS FOR ARTHRITIS

    • ALL NATURAL

    • FAST ACTING

    • LONG LASTING

    Topical Analgesic

    0.61 fl. oz. (18 mL)

    • Plant based medicine for pain relief

    • Fast acting and long lasting

    • Works for: aches, pains, & strains

    FLEX24®

    RECOVER NATURALLY

    20190828_73218_PainPen

  • INGREDIENTS AND APPEARANCE
    FLEX24 PAIN PEN 
    camphor liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73218-003
    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:73218-003-0118 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product08/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/28/2019
    Labeler - FLEX24, INC. (117114024)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dong E E Hua Medical Technology Co, Ltd527813247manufacture(73218-003)