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Imbue (Imbue Body LLC)

Available Formats

Dosage Form Package Information Links
PATCH 4 PATCH in 1 POUCH (75979-1146-4) Label Information
PATCH 1 PATCH in 1 POUCH (75979-1146-1) Label Information

Complete Imbue Information

  • 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.


  • INGREDIENTS AND APPEARANCE
    IMBUE  PAIN RELIEF
    menthol - methyl salicylate patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:75979-1146
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 51 mg
    Methyl salicylate (UNII: LAV5U5022Y) (salicylic acid - UNII:O414PZ4LPZ) Methyl salicylate 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:75979-1146-1 1 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 06/01/2011
    Labeler - Imbue Body LLC (965843878)
    Establishment
    Name Address ID/FEI Business Operations
    Taiwan Three Mast Pharmaceutical Company 658305156 manufacture