Top Medicated Oil

Manufacturer
Big 5 Nutrition LLC | Taiwan Shuenn-Ann Biotechnology Pharmaceutical Co., Ltd.
Effective date
2023-11-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:36

Label at a glance#

ProductTop Medicated Oil
Active ingredientCAMPHOR (NATURAL), MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure10 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints due to: • simple backache • arthritis  • strains • bruises • sprains 

Dosage and administration

• adults and children 12 years of age and older: apply 3 to 4 drops of medicated oil to the affected area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massage as shown in the illustrations.  • children under 12 years of age: consult your physician. • refer to the above warnings; use otherwise than as directed may be dangerous.

Storage and handling

• store at 16° to 30°C (61° to 86° F) • store in an airtight container

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 10%

Menthol 16%

Methyl Salicylate 40%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints due to:

• simple backache • arthritis  • strains • bruises • sprains 

Warnings

WARNINGS SECTION

For external use only

Do not use

• on wounds

• on irritated or damaged skin

• otherwise than as directed

When using this product

• avoid contact with the eyes or mucous membranes

• do not bandage tightly

Stop use and ask a 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

• nausea, vomiting, abdominal discomfort, diarrhea, or skin rashes occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 12 years of age and older: apply 3 to 4 drops of medicated oil to the affected area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massage as shown in the illustrations. 

• children under 12 years of age: consult your physician.

• refer to the above warnings; use otherwise than as directed may be dangerous.

Other information

STORAGE AND HANDLING SECTION

• store at 16° to 30°C (61° to 86° F) • store in an airtight container

Inactive ingredients

INACTIVE INGREDIENT SECTION

• Eucalyptus oil • Lavender oil

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

A&A MEDICAL SUPPLIES, INC.

S. El Monte, CA 91733 USA 

MADE IN TAIWAN

ITEM NO. HK105

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82198-0009-1Top Medicated Oil50 mL in 1 BOTTLEOIL502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82198-0009TOP MEDICATED OIL (CAMPHOR, MENTHOL, METHYL SALICYLATE) OIL [BIG 5 NUTRITION LLC]2Current NDC, 1 package rows20231122_b2f0d1e1-7d03-434e-be39-9f980459690c.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82198-000982198-0009-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
Top Medicated OilCAMPHOR, MENTHOL, METHYL SALICYLATEBig 5 Nutrition LLCb2f0d1e1-7d03-434e-be39-9f980459690c2023-11-21WarningsExact identifier
ndc (package): 82198-0009-1
ndc (product): 82198-0009
ndc11 (package): 82198000901
spl id: 0aa37a7b-8526-d9d5-e063-6294a90a23be
spl set id: b2f0d1e1-7d03-434e-be39-9f980459690c

Reported adverse events (FAERS/openFDA)#

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