TOP MEDICATED - camphor (natural), menthol,methyl salicylate oil 
A&A Medical Supplies

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.

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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:


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

Other Information

Inactive Ingredients

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


TopMedicatedOilA

TopMedicatedOilB

TOP MEDICATED 
camphor (natural), menthol,methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50943-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)10 mL  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 mL  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE50 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CLOVE OIL (UNII: 578389D6D0)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
TURPENTINE OIL (UNII: C5H0QJ6V7F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Sheng Chun Tang Pharmaceutical Industrial Co., Ltd.656347754manufacture

Revised: 6/2012
Document Id: 3b65d02e-38b1-4f67-8a30-fb7aa42d1ee2
Set id: eb440866-9a10-44ac-af1d-e76c4733325e
Version: 1
Effective Time: 20120601
 
A&A Medical Supplies