Label: FLEX24 PERFORMANCE- camphor menthol patch

  • 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 21, 2017

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  • Active Ingredients

    Camphor, 3%

    Menthol, 2.52%

  • 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
    ■ Bandage tightly

    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 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

    Pregnancy or Breast Feeding

    ask healthcare professional about use.

    Keep Out of Reach of Children

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

  • Directions

    ■ Peel desired length of tape and cut with serrated edge.
    ■ Discard plastic backing from tape                                     ■ Repeat as necessary, but no more than 3 per day
    ■ Apply tape to affected area.                                             ■ Tape should be comfortably tight
    ■ Children under 12, consult a doctor before use

  • Inactive Ingredients

    Angelica Dahurica, Cape Jasmine Fruit, Chinese Angelica, Cotton, Eucalyptus Oil, Ethyl Alcohol, Forsythia Seed Pod,
    Fortune’s Drynaria Rhizome, Frankincense, Kusnezoff Monkshood root, Lavender Oil, Manchurian Wild Ginger, Myrrh,
    Paper roll, Peppermint Oil, Pinellia Tuber, Red Peony Root, Rehmannia Root (raw), Rhubarb, Safflower, Slenderstyle
    Acanthopanax Bark, Tangerine Peel, Tree Peony Bark, Turmeric, Weeping Wintergreen Oil, White Peony Root,
    Zanthoxylum Nitidum, Zedoary.

  • 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.Flex24.com/performancetape

  • SPL UNCLASSIFIED SECTION

    Larasan Pharmaceutical Corp.

    1287 E. Newport Center Drive, Suite 206

    Deerfield Beach, FL 33442

  • PRINCIPAL DISPLAY PANEL

    20170117Flex24PerfTape

    20170117Flex24PerfTape.jpg

  • INGREDIENTS AND APPEARANCE
    FLEX24 PERFORMANCE 
    camphor menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54641-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.52 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    COTTON FIBER (UNII: 70LDW53ROO)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ALCOHOL (UNII: 3K9958V90M)  
    FORSYTHIA SUSPENSA FRUIT (UNII: P4793M1ES5)  
    DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    ACONITUM KUSNEZOFFII ROOT (UNII: 3L29I4K8KX)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GINGER (UNII: C5529G5JPQ)  
    MYRRH (UNII: JC71GJ1F3L)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PINELLIA TERNATA ROOT (UNII: G9AET085M5)  
    PAEONIA OBOVATA ROOT (UNII: 7NPF74465O)  
    REHMANNIA ELATA ROOT (UNII: 4PTH680I21)  
    RHUBARB (UNII: G280W4MW6E)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB)  
    TANGERINE PEEL (UNII: JU3D414057)  
    PAEONIA SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X)  
    TURMERIC (UNII: 856YO1Z64F)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54641-007-011 in 1 PACKAGE01/16/2017
    11.56 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/16/2017
    Labeler - Larasan Pharmaceutical Corporation (078350375)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dong-e E-jiao E-hua Medical Equipment Co Ltd527813247manufacture(54641-007)
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