Initial Drug Listing - RoyceDerm ANTIFUNGAL SOAP- 168

Manufacturer: RoyceDerm LLC
Effective date: 2026-03-05
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:51:20

Label at a glance#

ProductRoyceDerm ANTIFUNGAL .soap.

Active ingredientCLOTRIMAZOLE

Label structure9 sections

Contacts and useful links#

Websitewww.roycederm.com

www.roycederm.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

OTC - PURPOSE SECTION

Anti-fungal

DOSAGE & ADMINISTRATION SECTION

For effective treatment of most athlete's foot(tinea pedis), ringworm(tinea corporis) and jock itch(tinea cruris).
For effective relief of itching, burning and cracking skin.

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

Avoid contact with the eye.

OTC - STOP USE SECTION

Stop and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot & ringworm.

OTC - DO NOT USE SECTION

Do not use on children under 2 of age except under the advice and supervision of a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Wash affected area well and let product sit 2-3 minutes before rinsing
Make sure to dry affected area thoroughly.
Supervise children in the use of this product.
For Athlete's foot: pay special attention to the spaces between the toes; wearwell-fitting, ventilated shoes and change shoes and socks at least once daily.
Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.
This product is not effective on the scalp or nails.

OTHER SAFETY INFORMATION

Store at room temperature 59°-86°F (15°-30°C).

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, Monosodium Glutamate,Sodium Hydroxide, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide NP

OTC - QUESTIONS SECTION

Visit www.roycederm.com
Tel:+1(307)461-0958

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
251267	clotrimazole 1 % Medicated Bar Soap	PSN	1
251267	clotrimazole 0.01 MG/MG Medicated Bar Soap	SCD	1
251267	clotrimazole 1 % Medicated Bar Soap	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CLOTRIMAZOLE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85424-019-01	RoyceDerm ANTIFUNGAL .soap.	226 g in 1 CARTON	SOAP	226		1

Products#

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

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

RoyceDerm ANTIFUNGAL .soap.
Clotrimazole 1%
COCOS NUCIFERA (COCONUT) OIL
SODIUM MYRISTATE
SODIUM HYDROXIDE
SORBITOL
STEARIC ACID
OLEA EUROPAEA (OLIVE) FRUIT OIL
CERAMIDE NP
LAURIC ACID
PROPYLENE GLYCOL
MYRISTIC ACID
HAMAMELIS VIRGINIANA TOP
MONOSODIUM GLUTARATE
ELAEIS GUINEENSIS (PALM) OIL
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
WATER
CLOTRIMAZOLE
GLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85424-019	85424-019-01

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
Name	UNII	Kind
COCOS NUCIFERA (COCONUT) OIL	Q9L0O73W7L	IACT
SODIUM MYRISTATE	06BLC4V0IV	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SORBITOL	506T60A25R	IACT
STEARIC ACID	4ELV7Z65AP	IACT
OLEA EUROPAEA (OLIVE) FRUIT OIL	6UYK2W1W1E	IACT
CERAMIDE NP	4370DF050B	IACT
LAURIC ACID	1160N9NU9U	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
MYRISTIC ACID	0I3V7S25AW	IACT
HAMAMELIS VIRGINIANA TOP	UDA30A2JJY	IACT
MONOSODIUM GLUTARATE	36765054OO	IACT
ELAEIS GUINEENSIS (PALM) OIL	5QUO05548Z	IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL	VIF565UC2G	IACT
WATER	059QF0KO0R	IACT
CLOTRIMAZOLE	G07GZ97H65	ACTIB
GLYCERIN	PDC6A3C0OX	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RoyceDerm ANTIFUNGAL .soap.	CLOTRIMAZOLE 1%	RoyceDerm LLC	4c43e62b-9060-8962-e063-6394a90aff63	2026-03-05	Warnings	Exact identifier ndc (package): 85424-019-01 ndc (product): 85424-019 ndc11 (package): 85424001901 spl id: 4c43e62b-9061-8962-e063-6394a90aff63 spl set id: 4c43e62b-9060-8962-e063-6394a90aff63

Reported adverse events (FAERS/openFDA)#

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