Label: TRIMAZOLE- clotrimazole cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 11, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    • Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis).
    • Relieves itching, cracking, burning, and scaling, which accompany these conditions.
  • Warnings

    For external use only

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

    Ask a doctor before use if you are using any other medicines or cleansers on your skin.

    When using this product avoid contact with eyes; rinse immediately with cool tap water if contact occurs.

    Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks (for Athlete's Foot or Ringworm) or within 2 weeks (for Jock Itch).

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

    • Wash the affected area with soap and water and dry thoroughly.
    • Apply a thin layer of the product over the affected area twice daily (morning and night), or as directed by a doctor.
    • Supervise children in the use of this product.
    • For Athlete's Foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
    • For Athlete's Foot and Ringworm, use daily for 4 weeks; for Jock Itch, use daily for 2 weeks. If condition persists longer, consult a doctor.
    • This product is not effective on the scalp or nails.
    • Wash hands after each use.
  • Other information

    Store at 15-30°C (59-86°F). Avoid excessive heat.

    Do not use if product is damaged.

  • Inactive ingredients

    Aloe barbadensis leaf extract, aminomethyl propanol, caprylic / capric triglyceride, cetyl alcohol, disodium EDTA, glyceryl stearate, hydroxypropylcellulose, Lavandula angustifolia (lavender) oil, Melaleuca alternifolia (tea tree) oil, methylparaben, PEG 100 stearate, polyethylene glycol 400, polysorbate 20, polysorbate 60, propylene glycol, propylparaben, purified water, stearic acid.

  • Questions/Comments?

    (210) 944-6920

  • PRINCIPAL DISPLAY PANEL - 85 G Tube Pouch Label

    Tear at notch to open. Do not use if seal is broken.

    NDC 73352-570-01

    TRIFLUENT
    PHARMA™

    Trimazole™

    1% Clotrimazole

    Topical Antifungal Cream

    NET WT. 3 OZ. (85 G)

    PRINCIPAL DISPLAY PANEL - 85 G Tube Pouch Label
  • INGREDIENTS AND APPEARANCE
    TRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73352-570
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73352-570-011 in 1 POUCH06/10/2024
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM00506/10/2024
    Labeler - Trifluent Pharma LLC (117167281)
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