MedPath

Antifungal 1% Clotrimazole Cream

Defense 1% Clotrimazole antifungal cream

Approved
Approval ID

29698d9e-8449-ceee-e063-6394a90a366e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 27, 2025

Manufacturers
FDA

Twincraft Inc.

DUNS: 093248870

Products 1

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

Antifungal 1% Clotrimazole Cream

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code64412-2010
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Antifungal 1% Clotrimazole Cream
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 27, 2025
FDA Product Classification

INGREDIENTS (22)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SHEA BUTTERInactive
Code: K49155WL9Y
Classification: IACT
AZADIRACHTA INDICA SEED OILInactive
Code: 4DKJ9B3K2T
Classification: IACT
SODIUM GLUCONATEInactive
Code: R6Q3791S76
Classification: IACT
OATMEALInactive
Code: 8PI54V663Y
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
UREAInactive
Code: 8W8T17847W
Classification: IACT
CALOPHYLLUM TACAMAHACA SEED OILInactive
Code: 05G85L61OE
Classification: IACT
ETHYLHEXYL PALMITATEInactive
Code: 2865993309
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
CLOTRIMAZOLEActive
Quantity: 1 g in 100 mL
Code: G07GZ97H65
Classification: ACTIB
SAFFLOWER OILInactive
Code: 65UEH262IS
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM POLYACRYLATE (8000 MW)Inactive
Code: 285CYO341L
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/1/2024

Artwork

Defense Antifungal Cream Artwork

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/1/2024

Uses

Proven clinically effective in the 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.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2024

Inactive Ingredients

Inactive ingredients: Allantoin, Avena Sativa (Oat) Kemel Flour, Butyrospermum Parkii (Shea) Butter,
Calophyllum Tacamahaca Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Cellulose Gum, Cetearyl Alcohol,
Citric Acid, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate. Melia Azadirachta Seed Oil, Microcrystalline
Cellulose, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Sodium Gluconate, Sodium Polyacrylate,
Urea, Water, Xanthan Gum

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/1/2024

Active Ingredient

Active ingredients: Clotrimazole 1.0%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/1/2024

Purpose

Antifungal

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/1/2024

Warnings

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2024

Directions

Directions Wash and diy affected area thoroughly. Apply a thin layer over affected area twice daily
(moming and night). Supervise children in the use of this product. For athlete’s foot: pay special attention
to the spaces between the toes. Wear well-fitting, ventilated shoes and change shoes and socks at least once
daily. For athlete’s foot and ringworm. use daily for 4 weeks. For jock itch, use daily for 2 weeks. If
condition persists longer, ask a doctor. This product is not effective on the scalp or nails

WARNINGS SECTION

LOINC: 34071-1Updated: 1/19/2024

Warnings

For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with eyes.

Stop use and ask a doctor if irritation occurrs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.