Label: GOLD MOUNTAIN BEAUTY INTENSIVE REPAIR SERUM- tolnaftate antifungal lotion

  • 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.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    Effectively relieves cracking, scaling and soreness accompanying fungus (tinea pedis)

    • Relieves Scaling and Cracking
    • Cures and prevents foot fungus tinea pedis (athlete's foot)
  • Warnings

    For external use only

    • 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

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

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

    Apply 1-2 pumps of serum onto each foot 2 times daily, paying special attention to rough areas.
    For keeping skin smooth, apply 1 pump on each foot once a day
    Supervise children in the use of this product

  • Other information

    Store at room temperature (59 - 86 degrees F)

  • Inactive ingredients

    Acetylated Lanolin Alcohol, Benzoic Acid, Cetyl Acetate, Cyclopentasiloane,

    Deionized Water, Dimethicone Copolyl, Dimethiconol, Ethoxydiglycol, Glycerin,

    Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil,

    Hydroxyethylacrylate/Sodium Acryloyldimethyl Taurate copolymer, Menthol (and) Menthyl Lactate,

    Olea Europaea (Olive) Oil, Phenoxyethanol, Phenyl Trimethicone, Polysorbate 60, Polysorbate 80,

    Propylene Glycol, Squalane, Talc.

  • QUESTIONS

    For questions or comments, please visit:

    goldmountainbeauty.com

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • GOLD MOUNTAIN Beauty FOOT THERAPY INTENSE HYDRATION INTENSIVE REPAIR SERUM

    Foot-Serum_BoxGMB_FootSerum_Bottle

  • INGREDIENTS AND APPEARANCE
    GOLD MOUNTAIN BEAUTY INTENSIVE REPAIR SERUM 
    tolnaftate antifungal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-418
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE2.8 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ACETATE (UNII: 4Q43814HXS)  
    2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    TALC (UNII: 7SEV7J4R1U)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SQUALANE (UNII: GW89575KF9)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    MENTHOL (UNII: L7T10EIP3A)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-418-021 in 1 BOX07/02/2018
    1NDC:76348-418-0128 g in 1 BOTTLE, PLASTIC; 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(76348-418)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!