Label: IMBUE PAIN RELIEF- menthol - methyl salicylate 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 February 1, 2011

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

  • ACTIVE INGREDIENT

    Active Ingredients

    Menthol 51 mg / patch

    Methyl Salicylate 15 mg / patch

    Purpose

    Topical Analgesic

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses: Temporarily relieves minor aches and pains of muscles and joints associated with:

    • simple backache  • muscle strain  • sprains  • arthritis  • bruises  • bursitis  • tendinitis.

  • WARNINGS

    Warnings FOR EXTERNAL USE ONLY


  • WHEN USING

    When using this product:

    • Use only as directed

    • Do not get into eyes or on mucus membranes

    • Do not apply to wounds, damaged or irritated skin

    • Do not bandage tightly or use with a heating pad


  • STOP USE

    Stop use and ask a doctor if:

    • Condition worsens

    • Severe skin irritation develops

    • Pain persists for more than 7 days

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health care professional before use.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children over 12 years:

    • Peel clear film off carefully. Avoid letting the sticky surface of the patch adhere to itself.

    • Place sticky surface of patch on skin, covering as much of the painful area as possible.

    • Leave in place for up to 8 hours. Pain relief is occasionally delayed.

    • Use 1 - 2 patches per day. Wait 12 - 24 hours before applying additional patches, to avoid skin irritation.

    • Wash hands after applying patch.

    • If patch is difficult to remove from skin, soak in warm water or vegetable oil, then peel off slowly.

    • Patch may be cut to size (before removing protective film) to treat smaller areas.

    • See Additional Tips for more helpful information.

    Children 12 years or younger: ask a doctor before use.

  • SPL UNCLASSIFIED SECTION

    Other Information 

    • This product may cause skin rash in some individuals.

    • Store in a cool area away from direct sunlight. 

    • Always re-seal pouch containing unused patches.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Acorus gramineus rhizome, Angelica sinensis root, Artemisia argyi leaf, Atractylodes lancea rhizome, black sesame oil, Boswellia carterii resin, Carthamus tinctorius flower, Cinnamomum verum bark, Cnidium monnieri fruit, Commiphora myrrha resin, Cyathula officinalis root, Cymbopogon citratus essential oil, Dioscorea hypoglauca rhizome, Drynaria fortunei rhizome, Eletherococcus nodiflorus root cortex, Ephemerantha fimbriata aerial parts, Gentiana macrophylla root, Helichrysum italicum essential oil, Lavandula angustifolia essential oil, Ligusticum chuanxiong root, Paeonia lactiflora root, Pinellia ternata rhizome, Pinus massoniana resin, Saussurea lappa root, zinc oxide.

  • PRINCIPAL DISPLAY PANEL

    image of package front
    image of package back


  • INGREDIENTS AND APPEARANCE
    IMBUE  PAIN RELIEF
    menthol - methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75979-1146
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol51 mg
    Methyl salicylate (UNII: LAV5U5022Y) (salicylic acid - UNII:O414PZ4LPZ) Methyl salicylate15 mg
    Inactive Ingredients
    Ingredient NameStrength
    Acorus gramineus root (UNII: Z60N6Q6E19)  
    Angelica sinensis root (UNII: B66F4574UG)  
    Artemisia argyi leaf (UNII: 2JYC99Q0WZ)  
    Atractylodes lancea root (UNII: CAZ6282J2O)  
    Sesame oil (UNII: QX10HYY4QV)  
    Frankincense (UNII: R9XLF1R1WM)  
    Safflower (UNII: 4VBL71TY4Y)  
    Cinnamon (UNII: 5S29HWU6QB)  
    Cnidium monnieri fruit (UNII: V1IA3S3CUS)  
    Myrrh (UNII: JC71GJ1F3L)  
    Cyathula officinalis root (UNII: BRM37UP34O)  
    West Indian lemongrass oil (UNII: 5BIA40E9ED)  
    HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    SAUSSUREA COSTUS ROOT (UNII: RUP970CGR9)  
    Zinc oxide (UNII: SOI2LOH54Z)  
    Dioscorea collettii var. hypoglauca root (UNII: N57RVD5L6U)  
    Drynaria fortunei root (UNII: 731W842X8Q)  
    Flickingeria fimbriata stem (UNII: D6E4A8IAEP)  
    Gentiana macrophylla root (UNII: 6559FC0U1B)  
    PINELLIA TERNATA ROOT (UNII: G9AET085M5)  
    Pinus massoniana resin (UNII: 64S07U83T7)  
    Rosin (UNII: 88S87KL877)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75979-1146-44 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/01/2011
    Labeler - Imbue Body LLC (965843878)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taiwan Three Mast Pharmaceutical Company658305156manufacture