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FDA Product

Antifungal Medicated Bar

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Antifungal Medicated Bar

85261-001

Regulatory Information

85261-001

M005

C200263

March 25, 2025

USA

RoyceDerm antifungal soap

HUMAN OTC DRUG LABEL

1

Company Information

621948245

Active Ingredients

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

Code: VIF565UC2G

Class Code: IACT

OLEA EUROPAEA (OLIVE) FRUIT OIL

Code: 6UYK2W1W1E

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

CERAMIDE NP

Code: 4370DF050B

Class Code: IACT

SULFUR

Code: 70FD1KFU70

Class Code: IACT

SORBITOL

Code: 506T60A25R

Class Code: IACT

LAURIC ACID

Code: 1160N9NU9U

Class Code: IACT

ELAEIS GUINEENSIS (PALM) OIL

Code: 5QUO05548Z

Class Code: IACT

SODIUM DODECYLBENZENESULFONATE

Code: 554127163Y

Class Code: IACT

SODIUM MYRISTATE

Code: 06BLC4V0IV

Class Code: IACT

SODIUM GLUTAMATE

Code: W81N5U6R6U

Class Code: IACT

COCOS NUCIFERA (COCONUT) OIL

Code: Q9L0O73W7L

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

MYRISTIC ACID

Code: 0I3V7S25AW

Class Code: IACT

HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER

Code: 8FP93ED6H2

Class Code: IACT

TOLNAFTATE

Quantity: 10 mg in 1 g

Code: 06KB629TKV

Class Code: ACTIB

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

Active Moieties

TOLNAFTATE

Code: 06KB629TKV

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