KOFAL FUERTE- methyl salicylate ointment 
PHARMADEL LLC

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Kofal Fuerte Rojo 4 Oz (KENIL)

Drug Facts

Drug Facts

Active ingredient and Purpose

Active ingredientPurpose
Mythyl Salicylate 15%Topical analgesic

Use

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

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

Other information

Inactive ingredients

Principal Display Panel

KOFAL ® Fuerte

Deportistas - Athletes

Pain relieving ointment

Pomada analgesico

4 oz (113 g)

PDP Kofal 4 Oz

KOFAL FUERTE 
methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
PARAFFIN (UNII: I9O0E3H2ZE)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAMPHOR, (-)- (UNII: 213N3S8275)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-107-04113 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 DrugM01712/03/2015
Labeler - PHARMADEL LLC (030129680)

Revised: 3/2024
Document Id: 14c3ca35-bea3-fd74-e063-6394a90a6299
Set id: 98488a07-eba0-2b4e-e053-2995a90ad6ab
Version: 4
Effective Time: 20240328
 
PHARMADEL LLC