ANTI-FUNGAL- clotrimazole cream 
MPM Medical, LLC

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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MP00023 - MPM Anti-Fungal Cream 4 oz.

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

MP00023 MPM Anti-Fungal Cream 4 oz

ANTI-FUNGAL 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66977-023
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
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TETRASODIUM EDETATE DIHYDRATE (UNII: 3JGX4KKZ4A)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66977-023-04113 g in 1 TUBE; Type 0: Not a Combination Product10/14/2002
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/14/2002
Labeler - MPM Medical, LLC (081241522)

Revised: 3/2022
Document Id: d9f4edaa-095b-7d9f-e053-2995a90a5349
Set id: 5315d252-6a7f-488e-9a0a-ccad18e57217
Version: 2
Effective Time: 20220311
 
MPM Medical, LLC