KEVUENO PAIN RELIEVING- camphor (natural), menthol and methyl salicylate ointment 
Prilumar Laboratorios

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.

----------

KeVUENO Pain Relieving Ointment

KeVUENO Pain Relieving Ointment


Active Ingredients

Camphor 5%

Menthol 10%

Methyl Salicylate 13%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only. Avoid contact with the eyes or mucous membranes.

When using this product

  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur within a few days
  • redness is present
  • excessive irritation of the skin develops

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 12 years of age and older: Apply to the affected area not more than 3 to 4 times daily
  • Children under 12 years of age: Consult a physician.

Other information

store in a cool place.

Inactive Ingredients

petrolatum

KeVUENO Pain Relieving Ointment 4oz (59478-000-01)

KevuenoLabel

KEVUENO PAIN RELIEVING 
camphor (natural), menthol, methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59478-000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)5 g  in 100 g
MENTHOL (MENTHOL) MENTHOL10 g  in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59478-000-01113 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/25/2013
Labeler - Prilumar Laboratorios (078891414)
Registrant - Prilumar Laboratorios (078891414)
Establishment
NameAddressID/FEIBusiness Operations
Prilumar Laboratorios078891414manufacture(59478-000)

Revised: 9/2013
Document Id: 26cd0251-8873-43b5-b37f-f74c6e74c06a
Set id: 40961ebb-c851-455b-a4c3-6b14c9f89332
Version: 1
Effective Time: 20130925
 
Prilumar Laboratorios