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Anti-Fungal by MPM Medical, Inc.

Medically reviewed on March 14, 2018

Dosage form: cream
Ingredients: CLOTRIMAZOLE 10mg in 1g
Labeler: MPM Medical, Inc.
NDC Code: 66977-023

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.

Anti-Fungal Cream

Active Ingredient

Clotrimazole 1%

Purpose

Anti-Fungal

Use

For the cure of athlete's foot (tinea pedis), jock itch (tinea cruris) and ring worm (tinea corporis).  For relief of itching, scaling, burning and discomfort that accompany these conditions.

Warnings

For exteranl use only.

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

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

Avoid contact with the eyes.

If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.

Keep out of reach of children

Directions

Clean the affected area and dry thoroughly. Apply a thin layer of the product 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 daily. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

Inactive Ingredients

Alkyl acrylate, Capric triglyceride, Cetearyl alcohol, Diazolidinyl urea, Hydroxyethylcellulose, Methylparaben, Propylparaben, Retinyl palmitate, Silica, Tetrasodium EDTA, Tocopheryl Acetate, Triethanolmine, Water

Package Label

ANTI-FUNGAL 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66977-023
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
TRICAPRIN 
CETOSTEARYL ALCOHOL 
DIAZOLIDINYL UREA 
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) 
METHYLPARABEN 
PROPYLPARABEN 
VITAMIN A PALMITATE 
SILICON DIOXIDE 
EDETATE DISODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:66977-023-04113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/14/2002
Labeler - MPM Medical, Inc. (119643406)
Establishment
NameAddressID/FEIOperations
Biomed Laboratories, LLC055329696manufacture(66977-023)

 
MPM Medical, Inc.

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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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