Herbal UTAPLAS External Analgesic Plaster

Herbal Utaplas External Analgesic Plaster by

Drug Labeling and Warnings

Herbal Utaplas External Analgesic Plaster by is a Otc medication manufactured, distributed, or labeled by Big 5 Nutrition LLC, TAIWAN SHUENN-AN BIOTECHNOLOGY PHARMACEUTICAL CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HERBAL UTAPLAS EXTERNAL ANALGESIC PLASTER- menthol, methyl salicylate patch 
Big 5 Nutrition LLC

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Herbal UTAPLAS External Analgesic Plaster

Analgesic

Drug Facts

• Active Ingredients: Purpose
• Menthol 4%: External Analgesic
• Methyl Salicylate 1%: External Analgesic

Uses

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

Warnings

For external use only

Do not use

● 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

● 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

● 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.

If pregnant, ask a health professional before use.

Keep out of reach of childrento avoid accidental poisoning.

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

Do not use otherwise than as directed.

Directions

● 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

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

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

Call:1-888-811-1133

Package Label

HERBAL UTAPLAS EXTERNAL ANALGESIC PLASTER 
menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82198-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.04 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)
YELLOW WAX (UNII: 2ZA36H0S2V)
MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)
FRANKINCENSE (UNII: R9XLF1R1WM)
SESAME OIL (UNII: QX10HYY4QV)
PINUS MASSONIANA RESIN (UNII: 64S07U83T7)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
ZINC OXIDE (UNII: SOI2LOH54Z)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
MYRRH (UNII: JC71GJ1F3L)
YELLOW OB (UNII: QE535CBH7S)

Product Characteristics
Color	green	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82198-0004-1	10 in 1 BAG	10/11/2021	11/28/2023
1		1.7 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/11/2021	11/28/2023

Labeler - Big 5 Nutrition LLC (114574559)

Establishment
Name	Address	ID/FEI	Business Operations
TAIWAN SHUENN-AN BIOTECHNOLOGY PHARMACEUTICAL CO., LTD.		656348265	manufacture(82198-0004) , pack(82198-0004) , label(82198-0004)

Revised: 11/2023

Document Id: 0b2fd634-285f-82d6-e063-6294a90a7883

34390-5

Set id: cea953d4-e106-3af4-e053-2a95a90af7b9

Version: 2

Effective Time: 20231127