FDA.reportPublic FDA data

Herbal Utaplas External Analgesic Plaster

Manufacturer
Big 5 Nutrition LLC | TAIWAN SHUENN-AN BIOTECHNOLOGY PHARMACEUTICAL CO., LTD.
Effective date
2021-10-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:32:04

Label at a glance#

ProductHerbal Utaplas External Analgesic Plaster
Active ingredientMENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints due to: ● arthritis ● strains ● bruises ● sprains ● simple backache

Dosage and administration

● Adults and children 12 years of age and older: clean and dry affected area. Remove plaster from the protective layer, apply to the affected area, rub the area with your hand to secure the patch. ● Plaster will remain effective for 8 hours. ● Avoid using the same patch on the same area for more than 2 days. ● Do not apply to area with excessive hair. Adhesive plaster may hurt skin upon removal. ● Wet patch with w...

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Analgesic

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsPurpose
Menthol 4%External Analgesic
Methyl Salicylate 1%External Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints due to:
● arthritis ● strains ● bruises ● sprains ● simple backache

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

● on wounds ● irritated or damaged skin ● sensitive skin
● with a heating pad ● if pregnant
● with, or as the same time as, other external analgesic products
● if allergic to aspirin or salicylates
● if allergic to any ingredients of this product.

When using this product

OTC - WHEN USING SECTION

● avoid contact with the eyes
● do not bandage tightly
● do not apply to wounds or damaged skin
● do not use more than 3 plasters a day
● do not use 1 hour before or after bathing

Stop use and ask a doctor if

OTC - STOP USE SECTION

● condition worsens
● symptoms persist for more than 7 days
● symptoms clear up and occur again within a few days
● excessive irritation of the skin develops
● rashes, itching or redness are present
● side effects occur.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental poisoning.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right
away.

OTC - DO NOT USE SECTION

Do not use otherwise than as directed.

Directions

DOSAGE & ADMINISTRATION SECTION

● Adults and children 12 years of age and older: clean and dry affected area.
Remove plaster from the protective layer, apply to the affected area, rub the area
with your hand to secure the patch.
● Plaster will remain effective for 8 hours.
● Avoid using the same patch on the same area for more than 2 days.
● Do not apply to area with excessive hair. Adhesive plaster may hurt skin upon
removal.
● Wet patch with warm water before removing from skin
● Children under 12 years of age: Do not use or consult a doctor.

Other Information

OTHER SAFETY INFORMATION

●Store unused patch in the pouch
●Store at room temperature, 20 to 25°C(68 to 77°F)

INACTIVE INGREDIENT SECTION

Chinese Clematidis Root & Rhizome, Yellow wax, Momordica cochinchinensis
seeds, Castor Seeds, Myrrh, Frankincense, Sesame Oil, Resin, FD&C Blue No. 2,
FD&C Yellow No. 4, Zinc Oxide

Questions or Comments

OTC - QUESTIONS SECTION

Call:1-888-811-1133

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FrontFrontBackBack

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82198-000482198-0004-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
CLEMATIS CHINENSIS ROOT8Z18N528CUIACT
YELLOW WAX2ZA36H0S2VIACT
MOMORDICA COCHINCHINENSIS SEED2T87O1UPVDIACT
FRANKINCENSER9XLF1R1WMIACT
SESAME OILQX10HYY4QVIACT
PINUS MASSONIANA RESIN64S07U83T7IACT
FD&C BLUE NO. 2L06K8R7DQKIACT
ZINC OXIDESOI2LOH54ZIACT
RICINUS COMMUNIS SEED7EK4SFN1TXIACT
MYRRHJC71GJ1F3LIACT
YELLOW OBQE535CBH7SIACT

Source Document#

Source XML

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
0b2fd634-285f-82d6-e063-6294a90a7883cea953d4-e106-3af4-e053-2a95a90af7b92023-11-27WarningsExact identifier
spl set id: cea953d4-e106-3af4-e053-2a95a90af7b9

Reported adverse events (FAERS/openFDA)#

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