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Tinea Versicolor Treatment Cream

Initial Drug Listing - Tinea Versicolor Treatment Cream

Approved
Approval ID

32d71d7e-3c78-6b63-e063-6294a90adaed

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 15, 2025

Manufacturers
FDA

Beautivity LLC

DUNS: 096573788

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Clotrimazole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85398-002
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Clotrimazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 15, 2025
FDA Product Classification

INGREDIENTS (9)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
TRIETHANOLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
CLOTRIMAZOLEActive
Quantity: 10 mg in 1 g
Code: G07GZ97H65
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
GENTIANA LUTEA ROOTInactive
Code: S72O3284MS
Classification: IACT
CAMPHOR (SYNTHETIC)Inactive
Code: 5TJD82A1ET
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/12/2025

packaging image

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/12/2025

Helps relieve & prevent itching, burning, cracking, and scaling associated with tinea nersicolor infections.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/12/2025

Clotrimazole 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/12/2025

Antifungal

WARNINGS SECTION

LOINC: 34071-1Updated: 5/12/2025

For External Use Only

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

avoid contact with eyes, if contact occurs, rinse the eyes very thoroughly with water.

Stop Using and Ask a Physician if irritation occurs or there is no improvement within 4 weeks.

keep out of the reach of young children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/12/2025
  • Wash the affected area and dry thoroughly.
  • Apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor, supervise children in the use of the product.
  • If the condition persists longer, consult a doctor.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/12/2025

Store at room temperature. Protect from excessive heat (above 104ºF/40ºC)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/12/2025

Purified Water, Camphor, Gentiana Lutea Root, Propylene Glycol, Glycerin, Methylparaben, Triethanolamine, Peppermint Oil

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/12/2025

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