CLOTRIMAZOLE ANTIFUNGAL- clotrimazole cream
Walgreen Company

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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Walgreen Co. Clotrimazole Antifungal 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

Clotrimazole Antifungal Cream

WALGREENS PHARMCIST RECOMMENDED

Clotrimazole Cream USP, 1%

Relieves itching & burning

Greaseless – Nonstaining

Compare to Lotrimin AF® active ingredient

Clotrimazole Antifungal Cream

Clotrimazole Cream USP, 1%

WALGREENS PHARMACIST RECOMMENDED

NET WT 0.5 OZ (14 g)

CLOTRIMAZOLE ANTIFUNGAL
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0857
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0857-64	1 in 1 CARTON	09/29/2017	07/15/2019
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0363-0857-58	1 in 1 CARTON	09/29/2017	11/30/2019
2		14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	09/29/2017	11/30/2019

Labeler - Walgreen Company (008965063)

Revised: 6/2019

Document Id: fe6d22c3-455a-49e2-b23b-bcdac89a3d93

Set id: 1bbc3c51-0776-429e-99b4-b80b02fdaf2e

Version: 2

Effective Time: 20190626

Walgreen Company