Label: FLEX24 PAIN- 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 August 28, 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 backache, 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 immedately
  • 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 over the age of 12:

    • Remove plastic backing from patch and discard
    • Apply one patch to affected area
    • Repeat if necessary, but no more than 3 per day
    • Patch should be comfortable but not tight
    • Sensitive skin – Remove patch under water

    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

  • SPL UNCLASSIFIED SECTION

    Download the FLEX24 App

    Dist: FLEX24, INC.

            4020 Galt Ocean Mile, Ste. 1607

            Ft. Lauderdale, FL 33308

           Tel: 844.4.FLEX24

    Formulated in the USA

  • PRINCIPAL DISPLAY PANEL

    FLEX24.COM

    FLEX24®

    RECOVER NATURALLY

    TOPICAL ANALGESIC PAIN PATCH

    24 Hour Relief

    7 Large Patches

    Patch size 8 cm x 13 cm

    All Natural

    Long Lasting

    Reduces Pain

    Strong Natural Pain Relief

    20190828_73218_patch

  • INGREDIENTS AND APPEARANCE
    FLEX24 PAIN 
    camphor, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73218-002
    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:73218-002-017 in 1 PACKAGE08/28/2019
    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 finalpart34808/28/2019
    Labeler - FLEX24 INC (117114024)
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