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 December 8, 2019

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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

    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

    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

    Adults and children over the age of 12:

    • Remove plastic backing from patch and discard

    • Apply one patch to affected area

    •Patch should be comfortable but not tight

    • Repeat if necessary but no more than 3 per day

    Children under 12, consult a doctor before use.

  • Inactive Ingredients

    Angelica Dahurica Root, Atractylodes Lancea Root, Borneol, Chinese Angelica, Chondroitin Sulfate, Ginger, Kaempferia Galanga Root, Kusnezoff Monkshood Root (raw), Lemon, Ligusticum Sinense/Subsp. Chuanxiong Root, Mineral Oil, Musk, Petrolatum, Radix Aconiti, Rosin, Silicone, Star Anise, Wintergreen Oil, Zinc Oxide

  • 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/performancepatch

  • SPL UNCLASSIFIED SECTION

    Flex24™ Performance Patch

    Quick Relief for the Pain Of

    Arthritis • Strains • Cramps • Bruises

  • Distributed By

    Distributed by:

    Larasan Pharmaceutical Corporation

    401 East Las Olas Blvd., Suite 1400

    Ft. Lauderdale, FL 33301

    Tel. 1-855-LARASAN

    NDC 54641-006-01

    Made in China

    Patch size 8 cm x 13 cm

  • PRINCIPAL DISPLAY PANEL

    Flex24™ Performance Patch
    24/7 Topical Analgesic
    Improve Performance
    Reduce Pain
    7 Large Patches
    Lasts Up to 24 Hours

    20140610 Flex24 Perf Patch

  • INGREDIENTS AND APPEARANCE
    FLEX24 PERFORMANCE 
    camphor, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54641-006
    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)  
    ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O)  
    BORNEOL (UNII: M89NIB437X)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    GINGER (UNII: C5529G5JPQ)  
    KAEMPFERIA GALANGA ROOT (UNII: 7B7U9D12AI)  
    ACONITUM KUSNEZOFFII ROOT (UNII: 3L29I4K8KX)  
    Lemon (UNII: 24RS0A988O)  
    LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MOSCHUS BEREZOVSKII MUSK SAC RESIN (UNII: Z70MFY52S4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X)  
    ROSIN (UNII: 88S87KL877)  
    STAR ANISE (UNII: XKC1657P78)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54641-006-017 in 1 PACKAGE04/08/2014
    11.56 g in 1 PATCH; Type 1: Convenience Kit of Co-Package
    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(54641-006)
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