Label: GOLD MOUNTAIN BEAUTY FUNGAL NAIL ELIMINATOR- tolnaftate antifungal oil

  • NDC Code(s): 76348-417-01, 76348-417-02
  • 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 14, 2022

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

  • Active Ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • 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
    • 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

  • OTHER SAFETY INFORMATION

    Other information

    Store at room temperature (59 - 86 degrees F)

  • Inactive ingredients

    C12-15 Alkyl Benzoate, Ethyldiglycol, Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Oil, Trimethylpentanediol/Adipic Acid Copolymer

  • ASK DOCTOR

    • If irritation occurs, discontinue use and consult a doctor
  • QUESTIONS

    For questions or comments, please visit: goldmountainbeauty.com

  • STOP USE

    • If irritation occurs, discontinue use and consult a doctor
  • INDICATIONS & USAGE

    Trim nails and file the surface using an emery board
    Apply a thin layer of product over affected areas twice daily (morning and night) especially around free edges of nails (under tips) and cuticles and the space around nails
    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

  • 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
    • If irritation occurs, discontinue use and consult a doctor
    • If swallowed, get medical help or consult a poison control center immediately.
  • DOSAGE & ADMINISTRATION

    Directions

    • Trim nails and file the surface using an emery board
    • Apply a thin layer of product over affected areas twice daily (morning and night) especially around free edges of nails (under tips) and cuticles and the space around nails
    • 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
  • PRINCIPAL DISPLAY PANEL

    GMB_Fungal-Nail-Box Approvedinternal GMB Label_multi layerGOLD MOUNTAIN

    Beauty

    Foot Therapy

    Antifungal

    Fungal Nail Eliminator

  • INGREDIENTS AND APPEARANCE
    GOLD MOUNTAIN BEAUTY FUNGAL NAIL ELIMINATOR 
    tolnaftate antifungal oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-417
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE0.14 g  in 14 g
    Inactive Ingredients
    Ingredient NameStrength
    THYME OIL (UNII: 2UK410MY6B)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    WINTER SAVORY OIL (UNII: EP61SM69Z2)  
    TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-417-021 in 1 BOX07/02/2018
    1NDC:76348-417-0114 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 finalpart333C07/02/2018
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories Inc.945739449manufacture(76348-417)