IMBUE PAIN RELIEF- menthol - methyl salicylate patch 
Imbue Body LLC

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.

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Drug Facts

Active Ingredients

Menthol 51 mg / patch

Methyl Salicylate 15 mg / patch

Purpose

Topical Analgesic

Topical Analgesic

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

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

Warnings FOR EXTERNAL USE ONLY


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 and ask a doctor if:

• Condition worsens

• Severe skin irritation develops

• Pain persists for more than 7 days

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

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

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.

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 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.

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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

Revised: 2/2011
Document Id: a8afe16c-2d30-4ace-a701-78f7a1856fa8
Set id: 1d94cc9e-c3dd-46e7-a425-4f6d64fac1b9
Version: 1
Effective Time: 20110201
 
Imbue Body LLC