Label: PAINFIX RESTORE- menthol patch

  • 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 20, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active Ingredients

    Menthol 7%

  • Purpose

    Topical analgesic

  • Uses

    Temporarily relieves aches and pains of joints and muscles associated with: • backache • arthritis • bursitis • tendonitis • cramps • strains • bruises • sprains

  • Warnings

    Avoid direct contact with eyes. For external use only.

    When using this product • use only as directed • avoid contact with eyes or mucous membranes • do not apply local heat to the area of use • do not apply to wounds, broken, damaged or irritated skin

    Stop use and ask a doctor if • condition worsens or symptoms persist for more than 7 days • skin irritation develops or you experience signs of skin injury, such as pain, swelling, or blistering where product is applied

    If pregnant or breast-feeding, ask a health professional before use.

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

  • Directions

    Adults and children above 12 years:
    • open pouch and remove patch
    • peel off protective backing and carefully apply sticky side to affected area
    • if affected area is large, use more than one patch for best results
    • use each patch for up to 15 hours
    • apply a new patch each day
    • cut the patch to fit smaller areas
    • for best results, use with recommended exercises

    Children 12 years and younger, ask a health professional

  • Other Information

    Store in a cool, dry place, away from direct sunlight.

  • Inactive Ingredients

    Acrylic Adhesive, Aloe Vera (Aloe Barbadensis) Extract, Wild Celery (Angelica Anomala) Extract, Arnica (Arnica Montana) Extract, Safflower (Carthamus Tinctorius) Extract, Camphor (Cinnamomum Camphora) Extract, Chinese Cinnamon (Cinnamomum Cassia) Extract, Mandarin Orange (Citrus Reticulata) Extract, Myrrh (Commiphora Molmol) Extract, Turmeric (Curcuma Longa) Extract, White Turmeric (Curcuma zedoaria) Extract, Dragon's Blood (Daemonorops Draco) Extract, Basket Fern (Drynaria Fortunei) Extract, Mastic Sap (Pistacia Lentiscus) Extract, Tibetan Rhubarb (Rheum Officinale) Extract, Baikal Skullcap (Scutellaria Baicalensis) Extract.

  • SPL UNCLASSIFIED SECTION

    UNLOCK YOUR BODY

    TAKE ME WITH YOU!

    I don't belong in the medicine cabinet. Throw me in your purse or gym bag, or take me along when you're exploring the world or pushing your limits. Think of me as a tool to unlock a higher experience for moments that matter in your life.

    1. Peel off the transparent layer
    2. Place the patch on the affected area. Use as many as you need.
    3. Use each patch for up to 15 hours.
    4. For best results, use the patch with the exercises in your personalized regimen.

    www.painfixbody.com

    Welcome to our community.

    Share your #UnlockedBody Story:

    Made in USA

    Manufactured for PainFix LLC
    195 Plymouth Street, Suite 404
    Brooklyn, New York 11201

  • Packaging

    Patch-008

  • INGREDIENTS AND APPEARANCE
    PAINFIX RESTORE 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72749-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM70 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANGELICA ANOMALA ROOT (UNII: 5YP3GQ626F)  
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
    CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0)  
    CINNAMOMUM CAMPHORA RESIN (UNII: J3614D61GX)  
    CHINESE CINNAMON (UNII: WS4CQ062KM)  
    CITRUS RETICULATA WHOLE (UNII: O0OX7CMF92)  
    MYRRH (UNII: JC71GJ1F3L)  
    TURMERIC (UNII: 856YO1Z64F)  
    CURCUMA ZEDOARIA ROOT (UNII: 123C43G128)  
    DRAGON'S BLOOD (UNII: M3YJ2C28IC)  
    DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)  
    PISTACIA LENTISCUS RESIN OIL (UNII: ZJ39788YVA)  
    RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72749-008-031 in 1 BOX01/07/2022
    15 in 1 POUCH
    10.18 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 finalpart34801/07/2022
    Labeler - PainFix LLC (116908667)