PRO-SERO PAIN RELIEF- menthol, methyl salicylate patch 
Tieh Leh Biotech Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients

Drug FactsMenthol 4%

Methyl Salicylate 1%

Purpose

Topical analgesic

Uses

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:

Warnings

For external use only

Alergy alert:

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Do not use

  • on the face or rashes
  • on wounds or damaged skin
  • if allergic to any ingredient of this product
  • on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if

  • you are allergic to topical products

When using this product

  • wash hands after applying or removing patch
  • avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

  • rash, itching or skin irritaion develops
  • condition worsens
  • symptoms last for more than 7 days
  • symptoms clear up and occur again within a few days

If pregnant or breast-feeding

  • ask a health professional before use

Keep our of reach of children. Package not child resistant.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

Adults and children 12 years of age and over:

Other information

Inactive ingredients

Clematis Chinensis Root, FD&C Yellow No. 5, Frankincense, Indigotindisulfonate Sodium, Momordica Cochinchinensis Seed, Myrrh, Ricinus Communis Seed, Rosin, Sesame Oil, Yellow Wax, Zinc Oxide

Questions or comments?

Visit www.pro-sero.com

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Principal Display

PRO-SERO PAIN RELIEF 
menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80846-100
Route of AdministrationTOPICAL, TRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE24 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL96 mg
Inactive Ingredients
Ingredient NameStrength
SESAME OIL (UNII: QX10HYY4QV)  
CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
INDIGOTINDISULFONATE SODIUM (UNII: D3741U8K7L)  
MYRRH (UNII: JC71GJ1F3L)  
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)  
PINUS MASSONIANA RESIN (UNII: 64S07U83T7)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80846-100-408 in 1 BOX10/12/2020
15 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2020
Labeler - Tieh Leh Biotech Co., Ltd. (656113256)
Establishment
NameAddressID/FEIBusiness Operations
Tieh Leh Biotech Co., Ltd.656113256manufacture(80846-100)

Revised: 9/2020
Document Id: b00bd912-a2c5-4cf0-e053-2995a90acf3b
Set id: b00bd912-a2c4-4cf0-e053-2995a90acf3b
Version: 1
Effective Time: 20200924
 
Tieh Leh Biotech Co., Ltd.