DYNAREX ANTIFUNGAL- clotrimazole cream 
Dynarex Corporation

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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Antifungal Cream

Active Ingredient

Active Ingredient                       Purpose

Clotrimazole 1.0%                     Antifungal                          

Purpose


  • For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
  • For the treatment of superficial skin infections caused by Yeast (Candida Albicans).
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.

Warnings

Do not use:

  • Do not use on children under 2 years of age unless directed by a doctor.
  • Avoid contact with eyes.
  • For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
  • For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

  • Clean the affected area and dry thoroughly. Apply a layer of cream 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 toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.

Dosage and Administration

  • Foe athlete's foot and ringworm, use daily for 4 weeks.
  • For jock itch, use daily for 2 weeks.If conditions persist longer, consult a doctor.
  • This product is not effective on scalp or nails.

Keep Out Of Reach Of Children

KEEP OUT Of REACH Of CHILDREN

INACTIVE INGREDIENTS

Inactive Ingredients: Cetomicrogol 1000, Cetostearyl alcohol, Liquid paraffin, Methylparaben, Propylene glycol, Propylparaben, Purified water, White soft paraben

Principal Display Panel

Dynarex Antifungal

Dynarex Antifungal Cream

Antifungal.jpg

DYNAREX ANTIFUNGAL 
antifungal cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67777-231
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETETH-20 
CETOSTEARYL ALCOHOL 
LIGHT MINERAL OIL 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
PETROLATUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-231-0228.25 g in 1 TUBE
2NDC:67777-231-01113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/18/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 5/2013
 
Dynarex Corporation