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Imbue Pain Relief by Imbue Body LLC

Dosage form: patch
Ingredients: Menthol 51mg, Methyl salicylate 15mg
Labeler: Imbue Body LLC
NDC Code: 75979-1146

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 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.



IMBUE  PAIN RELIEF
menthol - methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75979-1146
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol51 mg
Methyl salicylate (salicylic acid) Methyl salicylate15 mg
Inactive Ingredients
Ingredient NameStrength
Acorus gramineus root 
Angelica sinensis root 
Artemisia argyi leaf 
Atractylodes lancea root 
Sesame oil 
Frankincense 
Safflower 
Cinnamon 
Cnidium monnieri fruit 
Myrrh 
Cyathula officinalis root 
West Indian lemongrass oil 
HELICHRYSUM ITALICUM FLOWER OIL 
LAVENDER OIL 
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT 
PAEONIA LACTIFLORA ROOT 
SAUSSUREA COSTUS ROOT 
Zinc oxide 
Dioscorea collettii var. hypoglauca root 
Drynaria fortunei root 
Flickingeria fimbriata stem 
Gentiana macrophylla root 
PINELLIA TERNATA ROOT 
Pinus massoniana resin 
Rosin 
Packaging
#Item CodePackage Description
1NDC:75979-1146-44 PATCH (PATCH) 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/FEIOperations
Taiwan Three Mast Pharmaceutical Company658305156manufacture

Revised: 02/2011
 
Imbue Body LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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