Update-85398-010-01

Manufacturer: Beautivity LLC
Effective date: 2026-06-29
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: monthly-update
Hydrated at: 2026-07-17 21:36:54

Label at a glance#

ProductHermon Clotrimazole antifungal treatment cream

Active ingredientCLOTRIMAZOLE

Label structure9 sections

Storage and handling

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

Contacts and useful links#

PhonePoison Help1-800-222-1222

Websitewww.hermonhealth.com

www.hermonhealth.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Cotrimazole 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, if contact occurs, rinse thoroughly with water.

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

in case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.
(1-800-222-1222)

INDICATIONS & USAGE SECTION

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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

OTC - QUESTIONS SECTION

visit us at www.hermonhealth.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
QR code link	QR Code	q-r.to/ATFGK		package.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b64d2752-34ef-378a-1f4f-8bff32b0d1ae	Product name	4	20250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Hermon Clotrimazole antifungal treatment cream
Clotrimazole 1%
BUTYLATED HYDROXYTOLUENE
GLYCEROL FORMAL
ALCOHOL
CLOTRIMAZOLE
WHITE PETROLATUM
CETOSTEARYL ALCOHOL
EDETATE DISODIUM
DIMETHYL SULFOXIDE
ETHYLPARABEN
WATER
MINERAL OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85398-010	85398-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
GLYCEROL FORMAL	3L7GR2604E	IACT
ALCOHOL	3K9958V90M	IACT
CLOTRIMAZOLE	G07GZ97H65	ACTIB
WHITE PETROLATUM	B6E5W8RQJ4	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
DIMETHYL SULFOXIDE	YOW8V9698H	IACT
ETHYLPARABEN	14255EXE39	IACT
WATER	059QF0KO0R	IACT
MINERAL OIL	T5L8T28FGP	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
2	2026-03-02	full-release	2026-06-01 01:48:21

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hermon Clotrimazole antifungal treatment cream	CLOTRIMAZOLE 1%	Beautivity LLC	3c9bd942-49c6-cada-e063-6394a90a3166	2026-06-29	Warnings	Exact identifier ndc (package): 85398-010-01 ndc (product): 85398-010 ndc11 (package): 85398001001 spl id: 5566e746-fd24-6a51-e063-6294a90a8c82 spl set id: 3c9bd942-49c6-cada-e063-6394a90a3166
Clotrimazole antifungal treatment kit	CLOTRIMAZOLE 1%	Beautivity LLC	3ceec52e-4089-9eb0-e063-6294a90ad52a	2026-06-29	Warnings	Exact identifier ndc (package): 85398-010-01 ndc11 (package): 85398001001

Reported adverse events (FAERS/openFDA)#

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