KOFAL- methyl salicylate ointment

Kofal by

Drug Labeling and Warnings

Kofal by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

KOFAL 
methyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-109-02	60 g in 1 JAR; Type 0: Not a Combination Product	01/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/21/2020

Labeler - Pharmadel LLC (030129680)