Label: VOTRIZA-AL- clotrimazole 1% lotion

  • NDC Code(s): 83035-1061-3
  • Packager: Singular Dreamer, Ltd dba True Marker
  • 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 May 24, 2023

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

  • Active ingredients

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    • For the cure of most fungal infections including related/associated to tinea pedis (athlete’s foot), tinea cruris (jock itch) and tinea corporis (ringworm).
    • For effective relief of itching, scaling,cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections
  • Warnings

    • For external use only.
    • 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 and ask a doctor if irritation occurs or if there is no improvement within 4 weeks,discontinue use and consult a doctor (within 2 weeks for jock itch).
    • Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use
  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    •  Clean the affected area and dry thoroughly.
    • Apply a thin layer of the product over 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 the 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.
  • Other information

    Protect the product in this container from excessive heat and direct sun.

  • Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetearyl Alcohol, Cetyl Esters, Ethylhexyl Palmitate, Ethylhexylglycerin, Hamamelis Virginiana (Witch Hazel), Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate-20, Sorbitan Stearate, Thymus Vulgaris (Thyme) Extract, Tocopheryl Acetate (Vitamin E), Triethanolamine.

  • Questions?

    304-742-2433

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    VOTRIZA-AL 
    clotrimazole 1% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83035-1061
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    THYME (UNII: CW657OBU4N)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83035-1061-31 in 1 CARTON05/20/2023
    130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/20/2023
    Labeler - Singular Dreamer, Ltd dba True Marker (129504103)
    Registrant - Singular Dreamer, Ltd dba True Marker (129504103)