KOFAL MAX POWER- menthol 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 Max Power Menthol 1.25% (WP)

Drug Facts

Active ingredient & Purpose

Active ingredientPurpose
Menthol 1.25% ..................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

  • 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

Other information

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

Kofal MP PDP

KOFAL  MAX POWER
menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-376
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-9 (UNII: 48Q180SH9T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TEA TREE OIL (UNII: VIF565UC2G)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALCOHOL (UNII: 3K9958V90M)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-376-05142 g in 1 JAR; Type 0: Not a Combination Product06/10/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/10/2023
Labeler - Pharmadel LLC (030129680)

Revised: 6/2023
Document Id: fe1f1408-b0cc-67a4-e053-6394a90ad609
Set id: fe1f1408-b0cb-67a4-e053-6394a90ad609
Version: 1
Effective Time: 20230614
 
Pharmadel LLC