Label: HC MAX ANTI FUNGAL- tolnaftate 1% ointment

  • NDC Code(s): 0295-6629-06
  • Packager: Denison Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 11, 2020

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  • ACTIVE INGREDIENT

    Active ingredient

    Tolnaftate 1%

  • PURPOSE

    Purpose

    Anti-Fungal

  • INDICATIONS & USAGE

    Uses

    • Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).
    • Helps prevent most athlete's foot with daily use.
    • For effective relief of itching, burning and cracking.
  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use on children under 2 years of age unless directed by a doctor.

    When using this product

    • avoid contact with eyes.
  • STOP USE

    Stop use and ask a doctor if

    • Irratation occurs.
    • There is no improvement within 4 weeks.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP THIS AND ALL MEICATION OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, contact a physican, emercy medical car facility or Poison Control Center immediately for advice.

  • DOSAGE & ADMINISTRATION

    Directions

    • Clean affected area with soap and warm water and dry throrughy
    • Apply a thin layer of HC Max TM Anti-fungal Ointment over affeted area twice daily (morning and night) or as directed by a doctor.
    • Wear well-fitting, ventilated shoes, and change shoes and socks at least once dialy.
    • For athlete's foot pay special atnetion to spaces between the toes.
    • For athlete's foot and ringworm, use daily for 4 weeks.
    • For toes fungus, apply under nail and around cuticle area. If condition persists longer, consult a doctor.
    • This product is not effective on the scalp or nails.
    • Supervise children in the use of this product.
  • OTHER SAFETY INFORMATION

    Other information

    Store at controlled room temperature 15º-30º C (59º-86ºF) Do not permit to freeze.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Purified Water USP, Carborner Homopolymer Type A (Alyl Pentaerythritol Crosslinked), Phenoxyethanol. Dimethicone 350, Glyceryl Monostearate, Poloxamer 188, Aloe Vera Leaf, Eucalyptol, Lavender Oil, Olive Oil, Tea Tree Oil, Sodium Hydroxide.

  • PRINCIPAL DISPLAY PANEL

    labellabel 2

  • INGREDIENTS AND APPEARANCE
    HC MAX ANTI FUNGAL 
    tolnaftate 1% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-6629
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-6629-0628 g in 1 TUBE; Type 0: Not a Combination Product07/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/11/2019
    Labeler - Denison Pharmaceuticals, LLC (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(0295-6629)