Hy-Vee, Inc. Antifungal Foot Cream Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

ANTIFUNGAL FOOT- clotrimazole cream 
HyVee Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hy-Vee, Inc. Antifungal Foot Cream Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

• cures most athlete’s foot, jock itch and ringworm
• relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

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
• there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

• wash the affected area and dry 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, consult a doctor
• this product is not effective on the scalp or nails

Other information

• store at 20°-25°C (68°-77°F)

Inactive ingredients

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO the Active Ingredient of Lotrimin AF®

Antifungal Foot Cream

For Athlete’s Foot – Clotrimazole 1%

Cures Most Athlete’s Foot

Relieves Itching & Burning

Greaseless, Nonstaining Cream

NET WT 0.5 OZ (14 g)

ANTIFUNGAL FOOT 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42507-857
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ESTERS WAX (UNII: D072FFP9GU)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42507-857-58	1 in 1 CARTON	11/28/2015	04/01/2019
1		14 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 final	part333C	11/28/2015	04/01/2019

Labeler - HyVee Inc (006925671)

Revised: 7/2019

Document Id: 2e917e8c-6c06-43b3-a465-64fb7f334a82

34390-5

Set id: c4bcd489-fbdf-4023-8fde-56ebe8dc1b59

Version: 3

Effective Time: 20190725