Clotrimazole by Galentic Pharma (India) Private Limited CLOTRIMAZOLE cream

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient
Clotrimazole 1.0%

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:
  • Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes

Stop use and ask doctor if

• Irritation occurs
• There is no improvement in 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

• KEEP OUT OF REACH OFCHILDREN

  If swallowed, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

• Wash affected area and dry thoroughly
• Apply 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 conditions persists longer, ask a doctor
• This product is not effective on scalp or nails.

OTHER INFORMATION

• Store between 15° and 30° C (59° and 86°F)
• Lot No. & Exp. Date: See box or crimp of tube.

INACTIVE INGREDIENTS

Cetomacrogol 1000, Cetostearyl alcohol, Liquid paraffin, Methylparaben, Propylene glycol, Propylparaben, Purified water, White soft paraffin

SPL UNCLASSIFIED SECTION

Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,

Gandhidham-370 230, Gujarat. India

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Galentic

Clotrimazole
Cream
ANTIFUNGAL

Relieves
itching, burning, cracking & scaling
Cures most Athlete's Foot

NET WT.
1 OZ. (28g)

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-025
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
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MINERAL OIL (UNII: T5L8T28FGP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-025-13	1 in 1 CARTON	08/07/2013
1		28 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	08/07/2013

Labeler - Galentic Pharma (India) Private Limited (915110464)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Private Limited		650970176	analysis(50382-025) , manufacture(50382-025) , pack(50382-025) , repack(50382-025) , sterilize(50382-025)