Label: DR CANUSO FUNGAL NAIL ERASER- tolnaftate oil oil

  • NDC Code(s): 76348-410-02
  • 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

    Active Ingredient

    Tolnaftate 1%

  • PURPOSE

    Purpose

    Antifungal

  • Uses

    • Helps cure most fungal nail and skin infections including Fungus (Tinea Pedis)
    • Effectively relieves cracking, scaling and soreness accompanying the above conditon
  • WARNINGS

    Warnings

    For external use only

    • Do not use on children under 2 years of age unless directed by a doctor
    • Avoid contact with eyes, ears or mouth
    • Stop use and ask a physician if rash or irritation occurs
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding ask a health Professional before use

  • Directions

    • Trim nails and file the surface of nails using an emory board
    • Apply a thin layer of the product over affected areas twice daily (morning and night) especially around free edges of nails (under tips) and cuticles and the space around the toenails.
    • Allow solution to soak into nail or skin
    • Application to adjacent nails is recommended to prevent the spread of infection
    • Keep affected areas clean and dry throughout the day
    • Supervise children in the use of this product
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Cinnamomum Zeylanicum (Cinnamon Leaf) Oil, Ethoxydiglycol, Ethyl Macadamiate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive Oil), Trimethylpentanediol/Adipic Acid Copolymer.

  • QUESTIONS

    Questions or Comments?

    Visit www.DrCanuso.com

  • DOSAGE & ADMINISTRATION

    Uses

    • Helps cure most fungal nail and skin infections including Athlete's Foot (Tinea Pedis)
    • Effectively relieves cracking, scaling and soreness accompanying the above condition
  • LABEL FOR BOTTLED PRODUCT

    Multi Layer LABEL

  • Product BOX

    7915 Nail Eraser Box

  • INGREDIENTS AND APPEARANCE
    DR CANUSO FUNGAL NAIL ERASER 
    tolnaftate oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-410
    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
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    CINNAMON LEAF OIL (UNII: S92U8SQ71V)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-410-021 in 1 BOX08/11/2015
    114 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/11/2015
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-410)
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