KOFAL- methyl salicylate ointment 
Pharmadel LLC

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Kofal Fuerte Ointment 2 oz (KENIL)

Active ingredients & Purpose

Purpose

External Analgesic

Active ingredient Purpose
Methyl Salicylate 10.5%.............................External Analgesic

Uses

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 use

  • on broken or irritated skin
  • with a tight bandage
  • with a heating pad

Stop use and ask doctor immediately if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • excessive skin irritation occurs

If pregnant or breast-feeding,

ask a health care 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

camphor, menthol, methylparaben, paraffin, petrolatum, propylparaben.

Questions or comments?

1-866-359-3478 M-F 9 AM - 5 PM EST or www.pharmadel.com

Distributed by/ Distribuido por:

Pharmadel LLC, Georgetown, DE 199747

Package Label & Principal Display Panel

PDP Kofal 2oz

KOFAL 
methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR, (-)- (UNII: 213N3S8275)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-109-0260 g in 1 JAR; Type 0: Not a Combination Product01/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/21/2020
Labeler - Pharmadel LLC (030129680)

Revised: 4/2024
Document Id: 16b53577-ae01-6136-e063-6294a90af4aa
Set id: 9cac377d-97bc-f0b7-e053-2a95a90a2e12
Version: 4
Effective Time: 20240422
 
Pharmadel LLC