KOFAL T- 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.

----------

Kofal Fuerte Ointment 2 oz

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:

  • simple backache
  • arthritis
  • strains
  • sprains

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

  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor

Other information

  • store between 59° to 86°F (15° to 25°C)
  • do not use if seal over cap is broken, torn or missing

Inactive ingredients

camphor, menthol, methylparaben, paraffin wax, 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

KOFAL 2 OZ

KOFAL  T
methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-100
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 (SYNTHETIC) (UNII: 5TJD82A1ET)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-100-0260 g in 1 JAR; Type 0: Not a Combination Product01/03/201401/21/2020
2NDC:55758-100-04120 g in 1 JAR; Type 0: Not a Combination Product01/03/201409/09/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/21/201201/21/2020
Labeler - Pharmadel LLC (030129680)

Revised: 1/2020
Document Id: 9cac5734-166e-4910-e053-2995a90af828
Set id: d2cdaa04-3244-41b2-af5f-5bb37645bb43
Version: 7
Effective Time: 20200121
 
Pharmadel LLC