FDA.reportPublic FDA data

QUALI COLD

Manufacturer
Teh Seng Pharmaceutical Mfg. Co., Ltd
Effective date
2016-10-12
Label type
HUMAN OTC DRUG LABEL
Version
3218
Source
full-release
Hydrated at
2026-05-31 22:47:33

Label at a glance#

ProductQUALI COLD
Active ingredientMETHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC)
Label structure11 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with: Simple backache Arthritis Sprains Strains Bruises

Dosage and administration

1. Clean and dry the affected areas before application. 2. Remove the protective film while applying the areas 1-2 times daily, cut into smaller size if desired. If necessary up to 3 sheets per day. 3. Use only as directed. Firmly affix with adhesive tapes or elastic bandages around joint areas to secure the patch if needed.

Storage and handling

Store at room temperature away from direct sunlight. Properly sealed to remain fresh.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate    2.0%

Menthol     1.0%

Camphor      0.5%

Purpose

OTC - PURPOSE SECTION

Methyl Salicylate     Topical Analgesic

Menthol     Topical Analgesic

Camphor     Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Simple backache
Arthritis
Sprains
Strains
Bruises

Warnings

WARNINGS SECTION

1. For external use only. Avoid applying around the eyes and mucous membranes, or open wounds.
2. Pregnant women, nursing mothers and any person with allergic reactions to drugs or cosmetics should consult physician before use. Children should use this product under supervision.

Stop Use

OTC - STOP USE SECTION

Discontinue if skin irritation develops.

Keep Out of Reach Of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

1. Clean and dry the affected areas before application.
2. Remove the protective film while applying the areas 1-2 times daily, cut into smaller size if desired. If necessary up to 3 sheets per day.
3. Use only as directed. Firmly affix with adhesive tapes or elastic bandages around joint areas to secure the patch if needed.

Storage

STORAGE AND HANDLING SECTION

Store at room temperature away from direct sunlight. Properly sealed to remain fresh.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Phellodendron Amurense Whole

U.S. Sole Agent

SPL UNCLASSIFIED SECTION

Finemost Corp., Qualiherb

Cerritos, Ca 90703

Tel:   (562)802-0035

Fax: (562)802-0625

Made in Taiwan

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1812753camphor 0.5 % / menthol 1 % / methyl salicylate 2 % Medicated PatchPSN3218
1812753camphor 0.005 MG/MG / menthol 0.01 MG/MG / methyl salicylate 0.02 MG/MG Medicated PatchSCD3218
1812753camphor 0.5 % / menthol 1 % / methyl salicylate 2 % Medicated PatchSY3218

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67536-884-012023-01-30C16284748780-1f386c64a-1d73-0266-e053-dadaa90a7c1aTeh Seng Pharmaceutical Mfg. Co., Ltd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67536-884-01QUALI COLD16 g in 1 PACKETPATCH163218
67536-884-01QUALI COLD100 in 1 BOXPATCH1003218

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67536-884QUALI COLD (MENTHOL) PATCH [TEH SENG PHARMACEUTICAL MFG. CO., LTD]3218Legacy NDC, 2 package rows20161013_cdc30e63-917c-4aa7-901f-f76ad72f839b.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67536-88467536-884-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
PHELLODENDRON AMURENSE WHOLE3OZN5NGR9LIACT

Source Document#

Source XML · Source PDF

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
f97cbc68-a049-463e-8907-3ba503cdaea7cdc30e63-917c-4aa7-901f-f76ad72f839b2016-10-12WarningsExact identifier
spl id: f97cbc68-a049-463e-8907-3ba503cdaea7
spl set id: cdc30e63-917c-4aa7-901f-f76ad72f839b

Reported adverse events (FAERS/openFDA)#

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