Clotrimazole by The IBN SINA Pharmaceutical Industry Ltd. / The Ibn Sina Pharmaceutical Industry Ltd. CLOTRIMAZOLE cream

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by The IBN SINA Pharmaceutical Industry Ltd., The Ibn Sina Pharmaceutical Industry Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Clotrimazole 1%

PURPOSE

Purpose

Antifungal

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use on children under 2 years of age except under the advice and supervision of a doctor

WHEN USING

When using this product avoid contact with the eyes

STOP USE

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

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

DOSAGE & ADMINISTRATION

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
• 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

STORAGE AND HANDLING

Other information

• store at 2° - 30° C (36° - 86° F)
• Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients

cetostearyl alcohol, methylparaben, mineral oil, paraffin, polyoxyl 40 hydrogenated castor oil, polysorbate 80, water

QUESTIONS

Questions?

Call 1-833-IBN-SINA (1-833-426-7462)

SPL UNCLASSIFIED SECTION

Manufactured by:

The IBN SINA Pharmaceutical Industry Ltd.

Holding # A-80, Ward # 9, Shafipur, Kaliakoir

Gazipur-1751 Bangladesh

www.ibnsinapharma.com

Product of Bangladesh

PRINCIPAL DISPLAY PANEL

NDC: 72103-524-10

Clotrimazole Cream, USP 1%

Antifungal Cream

Net Wt. 0.35 oz (10g)

Cures Most Athlete's Foot, Jock Itch & Ringworm

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72103-524
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
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72103-524-10	1 in 1 CARTON	03/14/2019
1		10 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	03/14/2019

Labeler - The IBN SINA Pharmaceutical Industry Ltd. (731557752)

Establishment
Name	Address	ID/FEI	Business Operations
The Ibn Sina Pharmaceutical Industry Ltd.		731557752	manufacture(72103-524)