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Imbue

Imbue Body LLC

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients

Menthol 51 mg / patch

Methyl Salicylate 15 mg / patch

Purpose

Purpose

Topical Analgesic

Topical Analgesic

Uses

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.

ImbueImbue

Imbue

menthol - methyl salicylate PATCH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:75979-1146
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 51 mg
methyl salicylate METHYL SALICYLATE 15 mg

Inactive Ingredients

Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:75979-1146-4 4 in 1 POUCH

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2011-06-01


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Be sure to consult your doctor before taking any medication!
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