Label: KOFAL MAX POWER- menthol ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated June 14, 2023

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  • 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:

    • 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

    Kofal MP PDP

  • INGREDIENTS AND APPEARANCE
    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)
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