Label: DR. CANUSO FOOT REPAIR SERUM- tolnaftate serum lotion

  • NDC Code(s): 76348-409-02
  • Packager: Renu Laboratories, Inc.
  • 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 January 13, 2022

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  • ACTIVE INGREDIENT

    Tolnaftate 1%

  • PURPOSE

    Antifungal

  • WARNINGS

    When using this product

    • Do not use on children under 2 years of age unless directed by a doctor
    • Avoid contact with eyes
    • If irritation occurs, discontinue use and consult a doctor
    • If swallowed, get medical help or consult a poison control center immediately
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • STORAGE AND HANDLING

    Other Information

    Store at room temperature (59-86º F)

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Acetylated Lanolin Alcohol, Acryloyldimethyl Taurate Copolymer, Benzoic Acid, Cetyl Acetate, Cyclopentasiloxane, Dehydroacetic Acid, Deionized Water, Dimethiconol, Ethoxydiglycol, Glycerin, Menthol, Menthyl Lactate, Olea Europaea (Olive Oil), PEG-12 Dimethicone, Phenoxyethanol, Phenyl Trimethicone, Polysorbate 60, Polysorbate 80, Propylene Glycol, Squalane, Talc.

  • QUESTIONS

    Questions or Comments?
    Visit www.DrCanuso.com

  • INDICATIONS & USAGE

    Directions

    • Apply two pumps of serum onto each foot morning and night, paying special attention to rough cracked skin.
    • For maintenance of smooth skin, massage two pumps of serum into each foot once daily.
    • Supervise children in the use of this product.
  • DOSAGE & ADMINISTRATION

    Directions

    • Apply two pumps of serum onto each fot morning and night, paying special attention to rough cracked skin.
  • BOX ART_76348-407-02

    PRODUCT BOX

  • BOTTLE LABEL - Bottle resides in BOX

    Foot Serum bottle label

  • INGREDIENTS AND APPEARANCE
    DR. CANUSO FOOT REPAIR SERUM 
    tolnaftate serum lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-409
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE0.3 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    MENTHOL (UNII: L7T10EIP3A)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ACETATE (UNII: 4Q43814HXS)  
    ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
    WATER (UNII: 059QF0KO0R)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)  
    SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)  
    SQUALANE (UNII: GW89575KF9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Product Characteristics
    Colorwhite (Serum) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-409-021 in 1 BOX08/20/2015
    128 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/20/2015
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-409)
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