Pro-Sero Pain Relief

Manufacturer
Tieh Leh Biotech Co., Ltd.
Effective date
2020-09-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:28

Label at a glance#

ProductPro-Sero Pain Relief
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure9 sections

Indications and uses

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with: arthritis simple backache sprains strains bruises

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Drug FactsDrug FactsMenthol 4%

Methyl Salicylate 1%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • arthritis
  • simple backache
  • sprains
  • strains
  • bruises

Warnings

WARNINGS SECTION

For external use only

Alergy alert:

USER SAFETY WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • you are allergic to topical products

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • ask a health professional before use

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal DisplayPrincipal Display

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1874174menthol 4 % / methyl salicylate 1 % Medicated PatchPSN1
1874174menthol 0.04 MG/MG / methyl salicylate 0.01 MG/MG Medicated PatchSCD1
1874174menthol 4 % / methyl salicylate 1 % Medicated PatchSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80846-100-402022-01-28C16284748780-1d6a99b39-48ba-a426-e053-dadaa90af4c2b00bd912-a2c4-4cf0-e053-2995a90acf3b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80846-100-40Pro-Sero Pain Relief5 in 1 BAGPATCH51
80846-100-40Pro-Sero Pain Relief8 in 1 BOXPATCH81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80846-100PRO-SERO PAIN RELIEF (MENTHOL, METHYL SALICYLATE) PATCH [TIEH LEH BIOTECH CO., LTD.]1Legacy NDC, 2 package rows20201013_b00bd912-a2c4-4cf0-e053-2995a90acf3b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80846-10080846-100-40

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b00bd912-a2c5-4cf0-e053-2995a90acf3bb00bd912-a2c4-4cf0-e053-2995a90acf3b2020-09-24WarningsExact identifier
spl id: b00bd912-a2c5-4cf0-e053-2995a90acf3b
spl set id: b00bd912-a2c4-4cf0-e053-2995a90acf3b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.