ANTIFUNGAL 1% CLOTRIMAZOLE CREAM cream

Antifungal 1% Clotrimazole Cream by

Drug Labeling and Warnings

Antifungal 1% Clotrimazole Cream by is a Otc medication manufactured, distributed, or labeled by Twincraft Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Starch,
Urea, Water, Xanthan Gum

Active Ingredient

Active ingredients: Clotrimazole 1.0%

Purpose

Antifungal

Warnings

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

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

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.

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.

Artwork

INGREDIENTS AND APPEARANCE

ANTIFUNGAL 1% CLOTRIMAZOLE CREAM 
antifungal 1% clotrimazole cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64412-2010
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 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
UREA (UNII: 8W8T17847W)
CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CITRIC ACID (UNII: 2968PHW8QP)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)
SHEA BUTTER (UNII: K49155WL9Y)
SODIUM GLUCONATE (UNII: R6Q3791S76)
XANTHAN GUM (UNII: TTV12P4NEE)
OATMEAL (UNII: 8PI54V663Y)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM POLYACRYLATE STARCH (25 MICROMETER PARTICLE) (UNII: KXY4EH7RJV)
ALLANTOIN (UNII: 344S277G0Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: 64412-2010-1	1 in 1 CARTON	10/01/2024
1		29.5 mL 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	10/01/2024

Labeler - Twincraft Inc. (093248870)