CLOTRIMAZOLE JOCK ITCH- clotrimazole cream

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation, Sun Pharma Canada Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

• cures most jock itch
• relieves itching, burning, scaling, chafing and discomfort associated with jock itch

Warnings

For external use only

Do not useon children under 2 years of age unless directed by a doctor.

When using this productavoid contact with the eyes

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 2 weeks

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
• use daily for 2 weeks
• if condition persists longer, ask a doctor
• this product is not effective on the scalp or nails

Other information

• TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
• to open: unscrew cap, use the pointed end of cap to puncture seal.
• store between 20° to 25°C (68° to 77°F)
• see carton or tube crimp for lot number and expiration date

Inactive ingredients

2-octyldodecanol, benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, polysorbate 60, purified water, sorbitan monostearate

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
RITE AID, 200 NEWBERRY COMMONS

ETTERS, PA 17319

www.riteaid.com

MADE IN CANADA

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

Jock Itch Cream

Clotrimazole Cream, USP 1%

ANTIFUNGAL

NET WT 0.5 OZ (14.2 g)

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE   JOCK ITCH
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-3423
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 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)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-3423-1	1 in 1 CARTON	01/30/2023
1		14.2 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	01/30/2023

Labeler - Rite Aid Corporation (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharma Canada Inc.		243339023	manufacture(11822-3423)