Clotrimazole Cream

Clotrimazole Cream

Drug Labeling and Warnings

Drug Details

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CLOTRIMAZOLE- clotrimazole cream 
Galentic Pharma (India) Private Limited

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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Clotrimazole Cream

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 Of CHILDREN

    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

Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,
Gandhidham-370 230, Gujrat. 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)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50382-025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50382-025-131 in 1 CARTON08/07/2013
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C08/07/2013
Labeler - Galentic Pharma (India) Private Limited (915110464)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Private Limited864201135ANALYSIS(50382-025) , MANUFACTURE(50382-025) , PACK(50382-025) , REPACK(50382-025) , STERILIZE(50382-025)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-025) , MANUFACTURE(50382-025) , PACK(50382-025) , REPACK(50382-025) , STERILIZE(50382-025)

Revised: 1/2018
 
Galentic Pharma (India) Private Limited


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