Antifungal Clotrimazol Cream

Defense 1% Clotrimazole Antifungal Cream by

Drug Labeling and Warnings

Defense 1% Clotrimazole Antifungal Cream by is a Otc medication manufactured, distributed, or labeled by DEFENSE SOAP LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DEFENSE 1% CLOTRIMAZOLE ANTIFUNGAL CREAM- defense 1% clotrimazole antifungal cream cream 
DEFENSE SOAP LLC

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Antifungal Clotrimazol Cream

Active Ingredients

Active ingredients: Clotrimazole 1.0%

Purpose: Antifungal

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 the eyes.

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

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

Inactive Ingredients

Inactive ingredients: Allantoin, Avena Sativa (Oat) Kernel 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 Starch,
Urea, Water, Xanthan Gum

Directions

Directions Wash and diy affected area thoroughly. Apply a thin layer over affected area twice daily
(morning 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.

Purpose

Antifungal

Warnings

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

Uses

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.

Directions

Directions Wash and diy affected area thoroughly. Apply a thin layer over affected area twice daily
(morning 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

Artwork

DEFENSE 1% CLOTRIMAZOLE ANTIFUNGAL CREAM 
defense 1% clotrimazole antifungal cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70856-3584
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	6.75 g  in 100 g
SAFFLOWER OIL (UNII: 65UEH262IS)	4 g  in 100 g
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	2.08 g  in 100 g
PEG-100 STEARATE (UNII: YD01N1999R)	1.92 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	4.5 g  in 100 g
SHEA BUTTER (UNII: K49155WL9Y)	3 g  in 100 g
CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)	0.25 g  in 100 g
ALLANTOIN (UNII: 344S277G0Z)	0.25 g  in 100 g
WATER (UNII: 059QF0KO0R)	55.777625 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	9 g  in 100 g
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)	0.35 g  in 100 g
SODIUM POLYACRYLATE STARCH (25 MICROMETER PARTICLE) (UNII: KXY4EH7RJV)	0.3325 g  in 100 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.25 g  in 100 g
ETHYLHEXYL PALMITATE (UNII: 2865993309)	7 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.99 g  in 100 g
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)	0.85 g  in 100 g
SODIUM GLUCONATE (UNII: R6Q3791S76)	0.2 g  in 100 g
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)	0.15 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE)	0.1 g  in 100 g
OATMEAL (UNII: 8PI54V663Y)	1.25 g  in 100 g

Product Characteristics
Color	white (Opaque Cream)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70856-3584-1	1 in 1 CARTON	12/31/2023	01/19/2024
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	12/31/2023	01/19/2024

Labeler - DEFENSE SOAP LLC (780587353)

Revised: 1/2024

Document Id: 0f52f15b-c688-f5c0-e063-6394a90ae39c

34390-5

Set id: 0026fe0d-54f9-cd8d-e063-6294a90a1b3c

Version: 2

Effective Time: 20240119