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

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Herbal Utaplas External Analgesic Plaster

Drug Facts

Active Ingredients

Menthol               5%

Methyl Salicylate 1%

Purpose

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)

Inactive ingredients

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

label

HERBAL UTAPLAS EXTERNAL ANALGESIC PLASTER 
menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82198-0016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.06 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)  
INDIGOTINDISULFONATE SODIUM (UNII: D3741U8K7L)  
MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)  
MYRRH (UNII: JC71GJ1F3L)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
PINUS MASSONIANA RESIN (UNII: 64S07U83T7)  
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
SESAME OIL (UNII: QX10HYY4QV)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Product Characteristics
ColorgreenScore    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82198-0016-110 in 1 BAG01/01/2024
13.1 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)01/01/2024
Labeler - Big 5 Nutrition LLC (114574559)
Establishment
NameAddressID/FEIBusiness Operations
TAIWAN SHUENN-AN BIOTECHNOLOGY PHARMACEUTICAL CO., LTD.656348265manufacture(82198-0016) , pack(82198-0016) , label(82198-0016)

Revised: 11/2023
Document Id: 0b32b98c-2483-8d0c-e063-6294a90a90b1
Set id: aeaf070f-4512-4b8f-9bd8-960f6bb82881
Version: 1
Effective Time: 20231128
 
Big 5 Nutrition LLC