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Ultra Strength Pain Relief Balm

Medically reviewed on December 28, 2016

Dosage form: gel
Ingredients: CAMPHOR (NATURAL) 110mg in 1g, MENTHOL 110mg in 1g
Labeler: McCure Health Solutions Inc.
NDC Code: 52486-013

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.

Ultra Strength Pain Relief Balm

Drug Facts

Active ingredients

Camphor 11%

Menthol 11%

Purpose

Topical analgesic

Uses

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

Warnings

For external use only

When using this product
  • Avoid contact with eyes and mocous 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 daily

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

Product Label

ULTRA STRENGTH PAIN RELIEF BALM 
camphor, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52486-013
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)110 mg  in 1 g
MENTHOL (MENTHOL) MENTHOL110 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CAJUPUT OIL 
CLOVE OIL 
Packaging
#Item CodePackage Description
1NDC:52486-013-181 TUBE in 1 CARTON
118 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/27/2015
Labeler - McCure Health Solutions Inc. (053034873)
Establishment
NameAddressID/FEIOperations
Jiangsu Dedi Medical Device Co., Ltd.544458936manufacture(52486-013)

 
McCure Health Solutions Inc.

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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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