FDA.reportPublic FDA data

Gold Mountain Beauty Intensive Repair Serum

Manufacturer
Renu Laboratories, Inc.
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:55

Label at a glance#

ProductGold Mountain Beauty Intensive Repair Serum
Active ingredientTOLNAFTATE
Label structure10 sections

Indications and 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)

Dosage and administration

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

  • If irritation occurs, discontinue use and consult a doctor

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

Store at room temperature (59 - 86 degrees F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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.

OTC - QUESTIONS SECTION

For questions or comments, please visit:

goldmountainbeauty.com

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

GOLD MOUNTAIN Beauty FOOT THERAPY INTENSE HYDRATION INTENSIVE REPAIR SERUM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Foot-Serum_BoxFoot-Serum_BoxGMB_FootSerum_BottleGMB_FootSerum_Bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283693tolnaftate 1 % Topical LotionPSN3
283693tolnaftate 10 MG/ML Topical LotionSCD3
283693tolnaftate 1 % Topical LotionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-418-022024-01-30C16284748780-11030e365-1dca-111a-e063-dadaa90a10e2GOLD MOUNTAIN BEAUTY FOOT THERAPY INTENSIVE REPAIR SERUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-418-01Gold Mountain Beauty Intensive Repair Serum28 g in 1 BOTTLE, PLASTICLOTION283
76348-418-02Gold Mountain Beauty Intensive Repair Serum1 in 1 BOXLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-418GOLD MOUNTAIN BEAUTY INTENSIVE REPAIR SERUM (TOLNAFTATE ANTIFUNGAL) LOTION [RENU LABORATORIES, INC.]3Legacy NDC, 2 package rows20220115_7bd5c3b3-fe9a-f29a-e053-2a91aa0aa9ae.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-41876348-418-01, 76348-418-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ACETATE4Q43814HXSIACT
2-HYDROXYETHYL ACRYLATE25GT92NY0CIACT
POLYSORBATE 60CAL22UVI4MIACT
BENZOIC ACID8SKN0B0MIMIACT
TALC7SEV7J4R1UIACT
HIPPOPHAE RHAMNOIDES FRUIT OILTA4JCF9S1JIACT
CYCLOMETHICONENMQ347994ZIACT
POLYSORBATE 806OZP39ZG8HIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
OLIVE OIL6UYK2W1W1EIACT
TOLNAFTATE06KB629TKVACTIB
SQUALANEGW89575KF9IACT
DEHYDROACETIC ACID2KAG279R6RIACT
HIPPOPHAE RHAMNOIDES SEED OILT53SBG6741IACT
MENTHOLL7T10EIP3AIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
ACETYLATED LANOLIN ALCOHOLSSNN716810PIACT

Source Document#

Source XML

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
d58ff524-01c5-7574-e053-2995a90a7c527bd5c3b3-fe9a-f29a-e053-2a91aa0aa9ae2022-01-14WarningsExact identifier
spl id: d58ff524-01c5-7574-e053-2995a90a7c52
spl set id: 7bd5c3b3-fe9a-f29a-e053-2a91aa0aa9ae

Reported adverse events (FAERS/openFDA)#

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