FDA.reportPublic FDA data

SIMPLY VITAL Antifungal Cream

Manufacturer
ALPHA PLANTS INC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:15

Label at a glance#

ProductSIMPLY VITAL Antifungal Cream
Active ingredientCLOTRIMAZOLE
Label structure8 sections

Indications and uses

proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm. for effective relief of itching, scaling, burning, soreness, irritation and discomfort.

Dosage and administration

clean the affected area and dry thoroughly. apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. supervise children in the use of this product. for athlete's foot: Pay special attention to spaces between the toes; weat well-fitting, ventilated shoes, and change shoes and socks at least once daily. for athlete's foot and ringworm, use daily for 4 weeks. fo...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1.00%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses:

INDICATIONS & USAGE SECTION

  • proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm.
  • for effective relief of itching, scaling, burning, soreness, irritation and discomfort.

Warnings:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by a doctor 

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • irritation occurs.
  • condition persists.
  • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

Discontinue use and ask a doctor if

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

get medical help or contact a Poison Control Center right away. If swallowed,

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area and dry thoroughly.
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
  • supervise children in the use of this product.
  • for athlete's foot: Pay special attention to spaces between the toes; weat well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • for athlete's foot and ringworm, use daily for 4 weeks.
  • for jock itch, use daily for 2 weeks.
  • if condition persists longer, consult a doctor.
  • this product is not effective on the scalp or nails. 

Other information:

SPL UNCLASSIFIED SECTION

  • protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetearyl Alcohol, Cetyl Stearate, Ethylhexyl Palmitate, Ethylhexylglycerin, Glycerin, Hamamelis Virginiana (Witch Hazel), Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Sorbitan Stearate, Thymus Vulgaris (Thyme) Extract, Tocopheryl Acetate (Vitamin E), Triethanolamine.

Questions?

OTC - QUESTIONS SECTION

+1 (205) 624-9177

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN2
309367clotrimazole 10 MG/ML Topical CreamSCD2
309367clotrimazole 1 % Topical CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82460-344-00SIMPLY VITAL Antifungal Cream60 mL in 1 JARCREAM602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82460-344SIMPLY VITAL ANTIFUNGAL CREAM (CLOTRIMAZOLE) CREAM [ALPHA PLANTS INC]2Current NDC, Legacy NDC, 1 package rows20231112_d3842de3-0d13-4dc2-920b-90a4b822bbb8.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82460-34482460-344-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL STEARATE06RI5UQA7LIACT
ETHYLHEXYL PALMITATE2865993309IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSIACT
TEA TREE OILVIF565UC2GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
THYMECW657OBU4NIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
CLOTRIMAZOLEG07GZ97H65ACTIB

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
SIMPLY VITAL Antifungal CreamCLOTRIMAZOLEALPHA PLANTS INCd3842de3-0d13-4dc2-920b-90a4b822bbb82023-11-11WarningsExact identifier
ndc (package): 82460-344-00
ndc (product): 82460-344
ndc11 (package): 82460034400
spl id: 09e32c60-2b51-0226-e063-6294a90a6a2f
spl set id: d3842de3-0d13-4dc2-920b-90a4b822bbb8

Reported adverse events (FAERS/openFDA)#

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