ULTRA STRENGTH PAIN RELIEF BALM- camphor menthol ointment ointment 
Suzhou Vastech Medical Technology Co., Ltd

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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Active ingredients Purpose

Camphor 11%........................................................ Topical analgesic

Menthol 11%.......................................................... Topical analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with over-exertion, simple backache, arhtritis, strains, and sprains.

Warnings

For external use only.

When using this product

Stop use and ask a doctor if

If pregnant or breast feeding, ask a healthcare professional before use.

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center immediately.

Directions

Other information

This product may cause allergic reaction in some individuals. Test on small area before use.

Inactive ingredients

cajuput oil, clove oil, dementholized mint oil, paraffin petrolatuma

Distributed by:

MCURE HEALTH SOLUTIONS INC.

20819 Currier Rd #200

City of Industry, CA 91789

Made in China

PAIN RELIEF BALM

ULTRA STRENGTH PAIN RELIEF BALM 
camphor menthol ointment ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71183-320
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL11 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)11 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
CAJUPUT OIL (UNII: J3TO6BUQ37)  
CLOVE OIL (UNII: 578389D6D0)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71183-320-1818 g in 1 BOTTLE; Type 0: Not a Combination Product03/20/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/20/2017
Labeler - Suzhou Vastech Medical Technology Co., Ltd (543772485)
Registrant - Suzhou Vastech Medical Technology Co., Ltd (543772485)
Establishment
NameAddressID/FEIBusiness Operations
Suzhou Vastech Medical Technology Co., Ltd543772485manufacture(71183-320)

Revised: 3/2017
Document Id: 4a2aff23-e5a7-668f-e054-00144ff88e88
Set id: 4a2aff23-e5a6-668f-e054-00144ff88e88
Version: 1
Effective Time: 20170320
 
Suzhou Vastech Medical Technology Co., Ltd