FDA.reportPublic FDA data

Update-85398-003-01

Manufacturer
Beautivity LLC
Effective date
2026-06-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-07-17 21:37:06

Label at a glance#

ProductTinea Versicolor Treatment Bar
Active ingredientCLOTRIMAZOLE
Label structure9 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

coltrimazole 1%

OTC - PURPOSE SECTION

antifungal

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on Children under 2 years of age unless directed by a doctor.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes, if contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask doctor if irritation occurs or if there is no improvement within 2 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

  • Wash the affected area thoroughly and allow the product to sit for 1-2 minutes before rinsing.
  • Ensure the affected area is dried completely.
  • Apply 1-2 times daily for 4 weeks.
  • This product is not effective for use on the scalp or nails.

INACTIVE INGREDIENT SECTION

Melaleuca Alternifolia (Tea Tree) Leaf Oil, Water, Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzenesulfonate, Sulfur, Hamamelis Virginiana Root Bark, Ceramide

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

barbar

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

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85398-00385398-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOTRIMAZOLEG07GZ97H65ACTIB
STEARIC ACID4ELV7Z65APIACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
LAURIC ACID1160N9NU9UIACT
MYRISTIC ACID0I3V7S25AWIACT
SODIUM HYDROXIDE55X04QC32IIACT
SULFUR70FD1KFU70IACT
ELAEIS GUINEENSIS (PALM) OIL5QUO05548ZIACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT
SODIUM GLUTAMATEW81N5U6R6UIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSIACT
SODIUM MYRISTATE06BLC4V0IVIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-03-02full-release2026-06-01 01:48:19

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinea Versicolor Treatment BarCLOTRIMAZOLEBeautivity LLC33612382-2f12-e9f6-e063-6394a90aaee42026-06-29WarningsExact identifier
ndc (package): 85398-003-01
ndc (product): 85398-003
ndc11 (package): 85398000301
spl id: 5566dc99-c9b2-82de-e063-6294a90a45e5
spl set id: 33612382-2f12-e9f6-e063-6394a90aaee4
Tinea Versicolor Treatment KitCLOTRIMAZOLEBeautivity LLC3361d9a2-daf6-7749-e063-6294a90a36532026-06-29WarningsExact identifier
ndc (package): 85398-003-01
ndc11 (package): 85398000301

Reported adverse events (FAERS/openFDA)#

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