Label: PHYTOZINE RINGWORM TREATMENT MAXIMUM STRENGTH- tolnaftate ointment

  • NDC Code(s): 71229-101-11
  • Packager: The Sisquoc Healthcare Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 31, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    TOLNAFTATE 1%

  • PURPOSE

    ANTIFUNGAL

  • USES

    • CURES MOST RINGWORM
    • RELIEVES ITCHING, REDNESS, IRRITATION AND DISCOMFORT WHICH ACCOMPANY THIS CONDITION.
  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES.

    STOP USE AND ASK A DOCTOR IF

    • IRRITATION OCCURS
    • THERE IS NO IMPROVEMENT WITHIN 4 WEEKS.

    DO NOT USE ON CHILDREN UNDER 2 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    • For the cure of most ringworm (tinea corporis) and athlete’s foot (tinea pedis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation and discomforts which may accompany these conditions.
    • Wash affected area and dry thoroughly. Apply a layer of PHYTOZINE over the affected area twice daily (morning and night). Allow the cream to dry for at least 3 minutes before covering the affectedarea with clothing.
    • Wash hands after each application to preventthe chance of the infection spreading to other parts of the skin.
    • Most ringworm infections will require between 3-4 weeks of continuous daily treatment before the infection is completely eliminated.
    • Proper use of PHYTOZINE will eliminate most ringworm infections. If the condition persists longer, contact a physician or medical professional.
  • INACTIVE INGREDIENTS

    Water, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Polysorbate-20, Sodium Polyacrylate, Hydrogenated Polydecene, Trideceth-6, Glyceryl Stearate, PEG-100, Stearate, Propylene Glycol, Cetyl Alcohol, Oleth-10 Phosphate, Glycerin, Avena (Oat), Kernel Extract, Aloe Barbadensis Leaf Juice, Actrostaphylos Uva Ursi Leaf Extract, Propolis Extract, Theobroma Cacao
    (Cocoa) Seed Butter, Rosa Canina Fruit Oil, Camphor, Menthol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula
    Angustifolia (Lavender) Oil, Jasminum Officinale (Jasmine) Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Tocopheryl
    Acetate, Stearic Acid, Propylene Glycol, Butylene Glycol, Cetyl Hydroxyethylcellulose, Sodium Hydroxide, Phenoxyethanol , Ethylhexylglycerin

  • OTHER SAFETY INFORMATION

    Store between 20°c to 25°C (68° to 77°F)

  • PRINCIPAL DISPLAY PANEL

    Label Phytozine Retail Proof 1-17

    Insert Phytozine '17

  • INGREDIENTS AND APPEARANCE
    PHYTOZINE RINGWORM TREATMENT  MAXIMUM STRENGTH
    tolnaftate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71229-101
    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
    WATER (UNII: 059QF0KO0R)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OLETH-10 PHOSPHATE (UNII: Q95361F4VS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OAT (UNII: Z6J799EAJK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    MENTHOL (UNII: L7T10EIP3A)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)  
    JASMINUM OFFICINALE WHOLE (UNII: X3314B4SYD)  
    CLOVE LEAF OIL (UNII: VCA5491KVF)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71229-101-1128 g in 1 TUBE; Type 0: Not a Combination Product03/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/25/2019
    Labeler - The Sisquoc Healthcare Corporation (021517142)