Kofal Analgesic Fuerte

Kofal-T Fuerte by

Drug Labeling and Warnings

Kofal-T Fuerte by is a Otc medication manufactured, distributed, or labeled by PHARMADEL LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KOFAL-T FUERTE- 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 Analgesic Fuerte

Drug Facts

Drug Facts

Active ingredient and Purpose

• Active ingredient: Purpose
• Mythyl Salicylate 15%: Topical Analgesic

Use

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

• arthritis
• backaches
• 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

Inactive ingredients

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

Principal Display Panel

KOFAL - T® Fuerte

Deportistas - Athletes

Pain relieving ointment - Pomada analgesico

4 oz (113 g)

KOFAL-T FUERTE 
methyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	15 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
PARAFFIN (UNII: I9O0E3H2ZE)
EUCALYPTUS OIL (UNII: 2R04ONI662)
MENTHOL (UNII: L7T10EIP3A)
STEARIC ACID (UNII: 4ELV7Z65AP)
CAMPHOR OIL (UNII: 75IZZ8Y727)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-105-04	113 g in 1 JAR; Type 0: Not a Combination Product	12/03/2015	11/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/03/2015	11/25/2019

Labeler - PHARMADEL LLC (030129680)

Revised: 11/2019

Document Id: 9848a2a3-4529-6e62-e053-2995a90a1a0a

34390-5

Set id: 825a01b3-2532-b263-e053-2991aa0a11a0

Version: 4

Effective Time: 20191126