MedPath

Recuren Plus Antifungal Cream

Approved
Approval ID

3c28a93a-dd42-65b8-e063-6294a90ae6ab

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

REGENEREN PLUS LTD

DUNS: 226204743

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

MICONAZOLE NITRATE 2%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code87014-001
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
MICONAZOLE NITRATE 2%
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (17)

LICORICEInactive
Code: 61ZBX54883
Classification: IACT
BORNEOLInactive
Code: M89NIB437X
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
CLOVE OILInactive
Code: 578389D6D0
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
AQUAInactive
Code: 059QF0KO0R
Classification: IACT
ALOE VERA LEAF OILInactive
Code: JQ7YW886UQ
Classification: IACT
MATRICARIA RECUTITA FLOWERING TOPInactive
Code: 3VNC7T6Z02
Classification: IACT
TRIETHANOLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
PARAFFINUM LIQUIDUMInactive
Code: T5L8T28FGP
Classification: IACT
MICONAZOLE NITRATEActive
Quantity: 20 mg in 1 g
Code: VW4H1CYW1K
Classification: ACTIB
EUCALYPTUS GLOBULUS LEAF OILInactive
Code: 2R04ONI662
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/4/2025

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/4/2025

Anti-fungal for the effective treatment of Athlete's Foot, Jock Itch, Ringworm, Eczema, Tinea Versicolor, and fungal folliculitis.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/4/2025

1 Apply a small amount of cream to the affected area 2-3 times daily; 2 Ensure the skin in clean and dry before use; 3 For first-time users, perform a patch test on a small area of skin to check for sensitivity.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/4/2025

Antifungal

WARNINGS SECTION

LOINC: 34071-1Updated: 9/4/2025

For external use only

On children under 3 years of age

Store in a cool, dry place.

Irritation occurs or if there is no improvement within 4 weeks.

If swallowed, get medical help right away.

Avoid contact with the eyes

Irritation occurs or if there is no improvement within 4 weeks.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/4/2025

Miconazole Nitrate 2%

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/4/2025

Aqua (Water), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Eugenia Caryophyllus (Clove) Leaf Oil/Bud Oil, Aloe Barbadensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Eucalyptus Globulus Leaf Oil, Tocopherol, Borneol, Menthol, Stearic Acid, Petrolatum, Paraffinum Liquidum, Glycerin, Triethanolamine.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/4/2025

Please contact the email: service@recurenplus.co.uk

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