PRO-SERO PAIN RELIEF- menthol, methyl salicylate patch

Pro-Sero Pain Relief by

Drug Labeling and Warnings

Pro-Sero Pain Relief by is a Otc medication manufactured, distributed, or labeled by Tieh Leh Biotech Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Menthol 4%

Methyl Salicylate 1%

Purpose

Topical analgesic

Uses

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

• arthritis
• simple backache
• sprains
• strains
• bruises

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:

• clean and dry affected area
• remove patch from film and apply to affected area
• leave in place for up to 8 to 12 hours
• apply a new patch up to 3 times daily
• Children under 12 years of age: Consult a doctor

Other information

• store at 20 - 25 degrees Celsius (68-77 degrees Fahrenheit)
• avoid storing product in direct sunlight
• protect product from excessive moisture
• reseal unused patches in their pouch
• for some individuals, pain relief begins several hours after applying the patch

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

PRO-SERO PAIN RELIEF 
menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80846-100
Route of Administration	TOPICAL, TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	24 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	96 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80846-100-40	8 in 1 BOX	10/12/2020
1		5 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/01/2020

Labeler - Tieh Leh Biotech Co., Ltd. (656113256)

Establishment
Name	Address	ID/FEI	Business Operations
Tieh Leh Biotech Co., Ltd.		656113256	manufacture(80846-100)