KOFAL MAX POWER- menthol 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]

Drug Facts

Active ingredient & Purpose

• Active ingredient: Purpose
• Menthol 1.25% ..................: External analgesic

Uses

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

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only. Avoid contact with the eyes.

Do not

• apply on wounds or irritated skin
• bandage tightly

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

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: do not use, consult a doctor

Other information

• store between 59°- 86°F (15 - 30°C)
• do not use if clear seal over jar is broken, torn or missing

Inactive ingredients

alcohol, arnica montana flower, cannabis sativa (hemp) seed oil, camphor, carbomer 940, DMDM hydantoin, eucalyptus oil, isopropyl alcohol, nonoxynol-9, polysorbate 20, propylene glycol, tea tree oil, trolamine, water

Distributed by:

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

Principal Display Panel

INGREDIENTS AND APPEARANCE

KOFAL  MAX POWER
menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-376
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
NONOXYNOL-9 (UNII: 48Q180SH9T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TEA TREE OIL (UNII: VIF565UC2G)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-376-05	142 g in 1 JAR; Type 0: Not a Combination Product	06/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/10/2023

Labeler - Pharmadel LLC (030129680)