Herbal Utaplas External Analgesic Plaster

Manufacturer
Big 5 Nutrition LLC | TAIWAN SHUENN-AN BIOTECHNOLOGY PHARMACEUTICAL CO., LTD.
Effective date
2023-11-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:06:16

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#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol               5%

Methyl Salicylate 1%

Purpose

OTC - PURPOSE SECTION

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 childrento 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 ingredients

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

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82198-0016-1Herbal Utaplas External Analgesic Plaster3.1 g in 1 PATCHPATCH3.11
82198-0016-1Herbal Utaplas External Analgesic Plaster10 in 1 BAGPATCH101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82198-0016HERBAL UTAPLAS EXTERNAL ANALGESIC PLASTER (MENTHOL, METHYL SALICYLATE) PATCH [BIG 5 NUTRITION LLC]1Current NDC, 2 package rows20240101_aeaf070f-4512-4b8f-9bd8-960f6bb82881.zip

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
82198-001682198-0016-1

Ingredients#

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

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

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
Herbal Utaplas External Analgesic PlasterMENTHOL, METHYL SALICYLATEBig 5 Nutrition LLCaeaf070f-4512-4b8f-9bd8-960f6bb828812023-11-28WarningsExact identifier
ndc (package): 82198-0016-1
ndc (product): 82198-0016
ndc11 (package): 82198001601
spl id: 0b32b98c-2483-8d0c-e063-6294a90a90b1
spl set id: aeaf070f-4512-4b8f-9bd8-960f6bb82881

Reported adverse events (FAERS/openFDA)#

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