Top Medicated

Dosage form: oil
Ingredients: CAMPHOR (NATURAL) 10mL in 100mL, MENTHOL 16mL in 100mL, METHYL SALICYLATE 50mL in 100mL
Labeler: A&A Medical Supplies
NDC Code: 50943-001

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Top Medicated Oil

Top Medicated Oil


Active Ingredients

Camphor 10%

Menthol 16%

Methyl Salicylate 50%

Purpose

External Analgesic

Uses

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

  • simple backache
  • strains
  • bruises
  • arthritis
  • sprains


Warnings

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 rash occurs

Keep out of reach of children

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

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

Inactive Ingredients
  • Clove Oil
  • Lavender Oil
  • Turpentine Oil

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

TOP MEDICATED 
camphor (natural), menthol,methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50943-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)10 mL  in 100 mL
MENTHOL (MENTHOL) MENTHOL16 mL  in 100 mL
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE50 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CLOVE OIL 
LAVENDER OIL 
TURPENTINE OIL 
Packaging
#Item CodePackage Description
1NDC:50943-001-0150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34805/24/2012
Labeler - A&A Medical Supplies (801197380)
Registrant - Sheng Chun Tang Pharmaceutical Industrial Co., Ltd. (656347754)
Establishment
NameAddressID/FEIOperations
Sheng Chun Tang Pharmaceutical Industrial Co., Ltd.656347754manufacture

Revised: 06/2012
 
A&A Medical Supplies

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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