LOTRIMIN- clotrimazole cream
Delpharm Montreal 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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Lotrimin ®

Clotrimazole

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.

Directions

wash 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 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

Other information

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

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

Questions?

866-360-3226

Distributed by Bayer HealthCare LLC, Whippany, NJ 07981.

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

LOTRIMIN ®AF

clotrimazole cream

ANTIFUNGAL

NET WT 12g (0.42 OZ)

Lotimin 0963

LOTRIMIN
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69213-0963
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL ESTERS WAX (UNII: D072FFP9GU)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (White to Off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69213-0963-1	1 in 1 CARTON	02/01/2002
1		30 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:69213-0963-2	1 in 1 CARTON	02/01/2002
2		15 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:69213-0963-5	1 in 1 CARTON	02/01/2002
3		12 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:69213-0963-7	1 in 1 CARTON	02/01/2002
4		24 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	02/01/2002

Labeler - Delpharm Montreal Inc. (203565379)

Revised: 7/2020

Document Id: abab01b6-d625-754f-e053-2995a90ad840

Set id: 4e3c32fd-01ac-34e1-e054-00144ff88e88

Version: 10

Effective Time: 20200724

Delpharm Montreal Inc.

Lotrimin ® Clotrimazole