KOFAL ORIGINAL- methyl salicylate ointment 
PHARMADEL LLC

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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Kofal Original Blue 4 Oz (SKOTT)

Drug Facts

Drug Facts

Active ingredient and Purpose

Active ingredientPurpose
Mythyl Salicylate 12%........................................Topical Analgesic

Use

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

  • backaches
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only. Avoid contact with the eyes

Do not

  • apply to wounds or damaged skin
  • 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 again within a few days.

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 immediately.

Directions

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor

Other information

  • store in a cool dry place between (59-86°F)15-30°C
  • don’t use if seal over jar is broken, torn, or missing

Inactive ingredients

camphor, cetyl alcohol, eucalyptus oil, glyceryl monostearate, menthol, methylparaben, paraffin, propylene glycol, propylparaben,
stearic acid, trolamine, water

Principal Display Panel

KOFAL ® Original

Penetrating pain relieving ointment

Pomada analgesica con accion penetrante

4 oz (113 g)

PDP Kofal Blue 4 Oz

KOFAL ORIGINAL 
methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE12 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PARAFFIN (UNII: I9O0E3H2ZE)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAMPHOR OIL (UNII: 75IZZ8Y727)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-108-04113 g in 1 JAR; Type 0: Not a Combination Product12/03/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/03/2015
Labeler - PHARMADEL LLC (030129680)

Revised: 5/2022
 
PHARMADEL LLC