Dermatin Antifungal

Dosage form: cream
Ingredients: CLOTRIMAZOLE 0.01g in 1g
Labeler: Melaleuca, Inc.
NDC Code: 54473-206

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.

Dermatin Antifungal Cream Content of Label

Active ingredient
Clotrimazole 1%

Purpose
Antifungal

Uses

  • Cures most athlete's foot, jock itch, and ringworm
  • Relieves itching, burning, cracking, scaling, and discomfort accompanying these conditions

Warnings
For external use only

  • When using this product avoid contact with the eyes

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

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

Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a physician
  • children under 12 years of age should be supervised in the use of this product
  • for athlete's foot: pay special attention to 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
  • this product is not effective on scalp or nails

Other ingredients  acrylates/C10-30 alkyl acrylates crosspolymer, benzyl alcohol, cetyl alcohol, deionized water, dimethicone, glyceryl stearate and PEG-100 stearate, propylene glycol, SD alcohol 40B, steareth-2, steareth-21, stearic acid, T36-C5® Melaleuca alternifolia (Tea Tree) leaf oil, triethanolamine.

DERMATIN  ANTIFUNGAL
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-206
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
BENZYL ALCOHOL 
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CETYL ALCOHOL 
DIMETHICONE 
GLYCERYL MONOSTEARATE 
POLYOXYL 100 STEARATE 
PROPYLENE GLYCOL 
STEARETH-2 
STEARETH-21 
STEARIC ACID 
TEA TREE OIL 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:54473-206-0114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/19/2011
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIOperations
Melaleuca, Inc.139760102manufacture

Revised: 02/2011
 
Melaleuca, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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