FDA.reportPublic FDA data

Gold Mountain Beauty Fungal Nail Eliminator

Manufacturer
Renu Laboratories, Inc. | Renu Laboratories Inc.
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 23:46:54

Label at a glance#

ProductGold Mountain Beauty Fungal Nail Eliminator
Active ingredientTOLNAFTATE
Label structure13 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

For external use only

WARNINGS SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

OTHER SAFETY INFORMATION

Other information

Store at room temperature (59 - 86 degrees F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

OTC - ASK DOCTOR SECTION

  • If irritation occurs, discontinue use and consult a doctor

OTC - QUESTIONS SECTION

For questions or comments, please visit: goldmountainbeauty.com

OTC - STOP USE SECTION

  • If irritation occurs, discontinue use and consult a doctor

INDICATIONS & USAGE SECTION

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 SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GMB_Fungal-Nail-Box ApprovedGMB_Fungal-Nail-Box Approvedinternal GMB Label_multi layerinternal GMB Label_multi layerGOLD MOUNTAIN

Beauty

Foot Therapy

Antifungal

Fungal Nail Eliminator

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1362937tolnaftate 1 % Topical OilPSN9
1362937tolnaftate 10 MG/ML Topical OilSCD9
1362937tolnaftate 1 % Topical OilSY9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-417-022024-01-30C16284748780-11030e365-0989-111a-e063-dadaa90a10e2Gold Mountain Beauty Fungal Nail Eliminator

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-417-01Gold Mountain Beauty Fungal Nail Eliminator14 g in 1 BOTTLE, GLASSOIL149
76348-417-02Gold Mountain Beauty Fungal Nail Eliminator1 in 1 BOXOIL19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-417GOLD MOUNTAIN BEAUTY FUNGAL NAIL ELIMINATOR (TOLNAFTATE ANTIFUNGAL) OIL [RENU LABORATORIES, INC.]9Legacy NDC, 2 package rows20220115_6997ce4b-ead8-00bf-e053-2991aa0a6e08.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-41776348-417-01, 76348-417-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
THYME OIL2UK410MY6BIACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
WINTER SAVORY OILEP61SM69Z2IACT
TOLNAFTATE06KB629TKVACTIB
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S)587WKM3S9QIACT
OLIVE OIL6UYK2W1W1EIACT
HIPPOPHAE RHAMNOIDES FRUIT OILTA4JCF9S1JIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
TEA TREE OILVIF565UC2GIACT
HIPPOPHAE RHAMNOIDES SEED OILT53SBG6741IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d58ff524-01c2-7574-e053-2995a90a7c526997ce4b-ead8-00bf-e053-2991aa0a6e082022-01-14WarningsExact identifier
spl id: d58ff524-01c2-7574-e053-2995a90a7c52
spl set id: 6997ce4b-ead8-00bf-e053-2991aa0a6e08

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.