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ULTRA STRENGTH PAIN RELIEF BALM

Medically reviewed on Mar 20, 2017

Dosage form: ointment
Ingredients: MENTHOL 11g in 100g, CAMPHOR (SYNTHETIC) 11g in 100g
Labeler: MCURE HEALTH SOLUTIONS
NDC Code: 52486-320

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.

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 spraings

Warnings

For external use only

When using this product

  • Avoid contact with the eyes and mucous membranes
  • Do not apply to open wounds or damaged skin
  • Do not bandage or use heating pad

Stop use and ask a doctor if

  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than seven days
  • Pain clears up and then recurs a few days later

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

  • Rub well on the affected area. Repeat 3 to 4 times dailys.
  • For children 2-12 years, consult a doctor before use

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

ULTRA STRENGTH PAIN RELIEF BALM 
camphor menthol ointment ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52486-320
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL11 g  in 100 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)11 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAJUPUT OIL 
CLOVE OIL 
PETROLATUM 
PARAFFIN 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52486-320-1818 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/20/2017
Labeler - MCURE HEALTH SOLUTIONS (053034873)
Establishment
NameAddressID/FEIOperations
Suzhou Vastech Medical Technology Co., Ltd543772485manufacture(52486-320)

 
MCURE HEALTH SOLUTIONS

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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