Update-85398-012-01

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

Label at a glance#

ProductClotrimazole antifungal treatment kit
Active ingredientCLOTRIMAZOLE
Label structure9 sections

Storage and handling

Store at room temperature. Protect from excessive heat (above 104°F/ 40°C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

OTC - PURPOSE SECTION

Antifungal

DOSAGE & ADMINISTRATION SECTION

Proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tineacorporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.

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

avoide contact with eyes, lf contact occurs, rinse thoroughly with water.

OTC - ASK DOCTOR SECTION

irritation occurs or if there is no improvement within 2 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

For cream

  • Wash affected area & dry thoroughly.
  • Apply a thin layer over affected area twice dally (morning andnight).
  • Supervise children in the use of this product.
  • Use daily for 2 weeks.

For soap

  • Wet skin with warm water and lather soap.
  • Gently massage onto affected areas.
  • Rinse thoroughly and dry.
  • Use twice daily or as directed by a doctor.

INACTIVE INGREDIENT SECTION

For cream:

Purifed Water, White Petrolatum, Mineral Oil, Glycerol, Cetostearyl Alcohol, Glyceryl Mono-And Distearate, Dimethyl sulfoxide, Alcohol, Polyoxyethylene Lauryl Ether (Peregal 0), Edetate Disodium, Butylated Hydroxytoluene, Ethylparaben

For soap:

Melaleuca Alternifalla (Tea Tree) Leaf Oil, Aqua (Water), Sorbitol, Elaeis Guineensis (Palm) Olil, Cocos Nucifera (Coconut) Olil,Olea Europaea (0live) Fruit Oi, Propylene Glycol, Glycerin, stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur Thermal Water, Hamamelis Virginiana (WitchHazel)Extract, Ceramide

STORAGE AND HANDLING SECTION

Store at room temperature. Protect from excessive heat (above 104°F/ 40°C)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130199284897021GTIN-13: 0199284897021
EAN-13: 0199284897021
GTIN-12: 199284897021
UPC-A: 199284897021
GTIN storage (14 digits): 00199284897021
package.jpg
QR code linkQR Codeq-r.to/ATFGKpackage.jpg

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 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85398-01285398-012-01
85398-01085398-010-01
85398-01185398-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-03-02full-release2026-06-01 01:48:33

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hermon Clotrimazole antifungal treatment creamCLOTRIMAZOLE 1%Beautivity LLC3c9bd942-49c6-cada-e063-6394a90a31662026-06-29WarningsExact identifier
ndc (package): 85398-010-01
ndc (product): 85398-010
ndc11 (package): 85398001001
Hermon Clotrimazole antifungal soap. barCLOTRIMAZOLE 1%Beautivity LLC3cdcf8cc-510c-6115-e063-6294a90ac3ea2026-06-29WarningsExact identifier
ndc (package): 85398-011-01
ndc (product): 85398-011
ndc11 (package): 85398001101
Clotrimazole antifungal treatment kitCLOTRIMAZOLE 1%Beautivity LLC3ceec52e-4089-9eb0-e063-6294a90ad52a2026-06-29WarningsExact identifier
ndc (package): 85398-011-01
ndc (package): 85398-010-01
ndc (package): 85398-012-01
ndc (product): 85398-012
ndc11 (package): 85398001001
ndc11 (package): 85398001101
ndc11 (package): 85398001201
spl id: 55673edc-20cb-19f4-e063-6294a90aee7c
spl set id: 3ceec52e-4089-9eb0-e063-6294a90ad52a
Hermon Balanitis relief kitSULFUR 1X HPUSBeautivity LLC3dce086e-a4eb-4b21-e063-6394a90aa1b22025-09-02WarningsExact identifier
ndc (package): 85398-011-01
ndc11 (package): 85398001101

Reported adverse events (FAERS/openFDA)#

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