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Clotrimazole by Promex, LLC

Medically reviewed on December 4, 2017

Dosage form: cream
Ingredients: Clotrimazole 1g in 100g
Labeler: Promex, LLC
NDC Code: 58988-0022

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.

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 except under the advice and supervision of a doctor

When using this product

avoid contact with the eyes

Stop use and ask a doctor if
  • Irritation occursThere is no improvement within 4 weeks(for athlete's foot and ringworm) or 2 weeks (for jock itch)Do not use for diaper rash

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) or as directed by a doctor
  • 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 a day
  • For athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
  • If conditions persist longer, ask a doctor
  • This product is not effective on the scalp or nails

Other information
  • store between 2°and 30°C (36°and 86°F)

Inactive ingredients

Benzyl alcohol, Carbomer940, Cetyl alcohol, Glycerin, Glyceryl monostearate, Light liquid paraffin, Purified water, Stearic acid and Trolamine

Clotrimazole

CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-0022
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (Clotrimazole) Clotrimazole1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CARBOMER HOMOPOLYMER TYPE C 
CETYL ALCOHOL 
GLYCERIN 
GLYCERYL MONOSTEARATE 
PARAFFIN 
STEARIC ACID 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:58988-0022-11 TUBE (TUBE) in 1 BOX
128.35 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/04/2013
Labeler - Promex, LLC (789974388)

 
Promex, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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