FDA.reportPublic FDA data

Top Medicated

Manufacturer
A&A Medical Supplies | Sheng Chun Tang Pharmaceutical Industrial Co., Ltd.
Effective date
2012-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:32:09

Label at a glance#

ProductTop Medicated
Active ingredientCAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE
Label structure8 sections

Indications and uses

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

Dosage and administration

adults and children 3 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 massaged as shown in the illustrations. children under 3 years of age: consult your physician. refer to the above warnings; use otherwis e than as directed may be dangerous.

Storage and handling

store at 16 to 30 degrees C (16 to 86 degrees F) preserve in tight container

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 10%

Menthol 16%

Methyl Salicylate 50%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • simple backache
  • strains
  • bruises
  • arthritis
  • sprains

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION


Do not use

  • on wounds
  • on irritated or damaged skin
  • otherwise than as directed

OTC - WHEN USING SECTION

When using this product

  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly

OTC - STOP USE SECTION

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 rash 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 3 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 massaged as shown in the illustrations.
  • children under 3 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 degrees C (16 to 86 degrees F)
  • preserve in tight container

Inactive Ingredients

INACTIVE INGREDIENT SECTION

  • Clove Oil
  • Lavender Oil
  • Turpentine Oil

Top Medicated Oil 1.7oz/50ml (67473-601-01)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


TopMedicatedOilATopMedicatedOilA

TopMedicatedOilBTopMedicatedOilB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1193297camphor 10 % / menthol 16 % / methyl salicylate 50 % Topical OilPSN1
1193297camphor 100 MG/ML / menthol 160 MG/ML / methyl salicylate 500 MG/ML Topical OilSCD1
1193297camphor 10 % / menthol 16 % / methyl salicylate 50 % Topical OilSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50943-001-012020-01-31C16284748780-19d75b9d0-efe9-f424-e053-dadaa90a57ceTop Medicated Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50943-001-01Top Medicated50 mL in 1 BOTTLEOIL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50943-001TOP MEDICATED (CAMPHOR (NATURAL), MENTHOL,METHYL SALICYLATE) OIL [A&A MEDICAL SUPPLIES]1Legacy NDC, 1 package rows20120531_eb440866-9a10-44ac-af1d-e76c4733325e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q9411
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y1
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q9411
MENTHOLACTIVE MOIETYL7T10EIP3A1
METHYL SALICYLATEACTIVE MOIETYLAV5U5022Y1
CLOVE OILINACTIVE INGREDIENT578389D6D01
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
TURPENTINE OILINACTIVE INGREDIENTC5H0QJ6V7F1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50943-00150943-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (NATURAL)N20HL7Q941ACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
CLOVE OIL578389D6D0IACT
LAVENDER OILZBP1YXW0H8IACT
TURPENTINE OILC5H0QJ6V7FIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CLOVE OILCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
3 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
3 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8INHALANT / NASALNAExact identifier — unii candidate
2 equally ranked IID candidates

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
3b65d02e-38b1-4f67-8a30-fb7aa42d1ee2eb440866-9a10-44ac-af1d-e76c4733325e2012-06-01WarningsExact identifier
spl id: 3b65d02e-38b1-4f67-8a30-fb7aa42d1ee2
spl set id: eb440866-9a10-44ac-af1d-e76c4733325e

Reported adverse events (FAERS/openFDA)#

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