Imbue

Manufacturer
Imbue Body LLC | Taiwan Three Mast Pharmaceutical Company
Effective date
2011-02-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:29:06

Label at a glance#

ProductImbue Pain Relief
Active ingredientMenthol, Methyl salicylate
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Menthol 51 mg / patch

Methyl Salicylate 15 mg / patch

OTC - PURPOSE SECTION

Purpose

Topical Analgesic

Topical Analgesic

INDICATIONS & USAGE SECTION

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

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

WARNINGS SECTION

Warnings FOR EXTERNAL USE ONLY

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if:

• Condition worsens

• Severe skin irritation develops

• Pain persists for more than 7 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Front
Package Front

Package Back
Package Back




FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75979-1146-12019-10-29C16284748780-1960f7f55-d7ea-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75979-1146-1ImbuePain Relief1 in 1 POUCHPATCH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75979-1146IMBUE PAIN RELIEF (MENTHOL - METHYL SALICYLATE) PATCH [IMBUE BODY LLC]1Legacy NDC, 1 package rows20110805_696d2272-927a-4dfb-8d41-09dee113c014.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3A1
Methyl salicylateACTIVE INGREDIENTLAV5U5022Y1
MentholACTIVE MOIETYL7T10EIP3A1
salicylic acidACTIVE MOIETYO414PZ4LPZ1
Acorus gramineus rootINACTIVE INGREDIENTZ60N6Q6E191
Angelica sinensis rootINACTIVE INGREDIENTB66F4574UG1
Artemisia argyi leafINACTIVE INGREDIENT2JYC99Q0WZ1
Atractylodes lancea rootINACTIVE INGREDIENTCAZ6282J2O1
CinnamonINACTIVE INGREDIENT5S29HWU6QB1
Cnidium monnieri fruitINACTIVE INGREDIENTV1IA3S3CUS1
Cyathula officinalis rootINACTIVE INGREDIENTBRM37UP34O1
Dioscorea collettii var. hypoglauca rootINACTIVE INGREDIENTN57RVD5L6U1
Drynaria fortunei rootINACTIVE INGREDIENT731W842X8Q1
Flickingeria fimbriata stemINACTIVE INGREDIENTD6E4A8IAEP1
FrankincenseINACTIVE INGREDIENTR9XLF1R1WM1
Gentiana macrophylla rootINACTIVE INGREDIENT6559FC0U1B1
HELICHRYSUM ITALICUM FLOWER OILINACTIVE INGREDIENTO97ZV7726K1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOTINACTIVE INGREDIENTRR83T99U971
MyrrhINACTIVE INGREDIENTJC71GJ1F3L1
PAEONIA LACTIFLORA ROOTINACTIVE INGREDIENT3Z3866YW6P1
PINELLIA TERNATA ROOTINACTIVE INGREDIENTG9AET085M51
Pinus massoniana resinINACTIVE INGREDIENT64S07U83T71
RosinINACTIVE INGREDIENT88S87KL8771
SafflowerINACTIVE INGREDIENT4VBL71TY4Y1
SAUSSUREA COSTUS ROOTINACTIVE INGREDIENTRUP970CGR91
Sesame oilINACTIVE INGREDIENTQX10HYY4QV1
West Indian lemongrass oilINACTIVE INGREDIENT5BIA40E9ED1
Zinc oxideINACTIVE INGREDIENTSOI2LOH54Z1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75979-114675979-1146-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CinnamonCINNAMON5S29HWU6QBELIXIR / ORAL10.5 mg/5mlExact identifier — unii candidate
2 equally ranked IID candidates
RosinROSIN88S87KL877CAPSULE / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8INHALANT / NASALNAExact identifier — unii candidate
2 equally ranked IID candidates
Sesame oilSESAME OILQX10HYY4QVINJECTION / INTRAMUSCULAR70 %v/vExact identifier — unii candidate
2 equally ranked IID candidates
Zinc oxideZINC OXIDESOI2LOH54ZINJECTION, SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
6 equally ranked IID candidates
Zinc oxideZINC OXIDESOI2LOH54ZSUPPOSITORY / RECTAL375 mgExact identifier — unii candidate
6 equally ranked IID candidates
RosinROSIN88S87KL877TABLET, EXTENDED RELEASE / ORAL8.99 mgExact identifier — unii candidate
3 equally ranked IID candidates
Zinc oxideZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Zinc oxideZINC OXIDESOI2LOH54ZINJECTION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
RosinROSIN88S87KL877TABLET, COATED / ORAL10 mgExact identifier — unii candidate
3 equally ranked IID candidates
Zinc oxideZINC OXIDESOI2LOH54ZSOLUTION / RESPIRATORY (INHALATION)3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
Sesame oilSESAME OILQX10HYY4QVCAPSULE / ORAL2325 mgExact identifier — unii candidate
2 equally ranked IID candidates
CinnamonCINNAMON5S29HWU6QBCAPSULE / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
Zinc oxideZINC OXIDESOI2LOH54ZSOLUTION / INTRAVENOUS3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
31577dd2-d7ed-4239-a76c-52f1a5190c4c696d2272-927a-4dfb-8d41-09dee113c0142011-02-01WarningsExact identifier
spl id: 31577dd2-d7ed-4239-a76c-52f1a5190c4c
spl set id: 696d2272-927a-4dfb-8d41-09dee113c014

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.