MAX REVIVE PLASTER- menthol, methyl salicylate patch 
Big 5 Nutrition LLC

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MAXREVIVE ®PLASTER External Analgesic Plaster

Backache, Arthritis, Strains, Bruises, Sprains

Drug Facts

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

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with: ■ 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

Drug Facts(continued)


Stop use and ask 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 useotherwise 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.

Drug Facts(continued)

Directions (continued)

■ 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:1-800-617-2021

Package Label

BackFront

MAX REVIVE PLASTER 
menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82198-0002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.04 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
YELLOW OB (UNII: QE535CBH7S)  
CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)  
MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)  
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
MYRRH (UNII: JC71GJ1F3L)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
SESAME OIL (UNII: QX10HYY4QV)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
PINUS MASSONIANA RESIN (UNII: 64S07U83T7)  
Product Characteristics
ColorgreenScore    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82198-0002-15 in 1 BAG10/11/2021
11.7 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)10/11/2021
Labeler - Big 5 Nutrition LLC (114574559)
Establishment
NameAddressID/FEIBusiness Operations
TAIWAN SHUENN-AN BIOTECHNOLOGY PHARMACEUTICAL CO., LTD.656348265manufacture(82198-0002) , pack(82198-0002) , label(82198-0002)

Revised: 11/2023
Document Id: 0aa34a75-7a11-a1f9-e063-6394a90ac052
Set id: ce4a0aca-ef70-3a05-e053-2a95a90ae99e
Version: 2
Effective Time: 20231120
 
Big 5 Nutrition LLC