FUNGI NAIL TOE AND FOOT MS- zinc undecylenate and undecylenic acid ointment 
Kramer Laboratories

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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Undecylenic acid 5%

Zinc Undecylenate 20%

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Antifungal

In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.

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Proven effective in the treatment of most athletes foot (tinea pedis) and ringworm (tinea corporis). Helps prevent most athlete's foot with daily use. for effective relief of itching,burning and cracking.

Directions

Clean affected areas with soap and warm water and dry thoroughly. Apply a thin layer of Fungi-Nail Toe and Foot Anti-fungal ointment over affected area twice daily (morning and night) or as directed by doctor. Wear well-fitting ventilated shoes, and change shoes and socks at least once daily. For athletes foot pay special attention to spaces between the toes. For athletes foot and ringworm , use daily for 4 weeks. For toe fungus, apply under nail and around cuticle area. If condition persists longer, consult a doctor. This product is not effective on scalp or nails. Supervise children in the use of this product.

Emulsifying wax NF, methylparaben, mineral oil, propylparaben, white petrolatum

Warnings for external use only.

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

Avoid contact with eyes.

image of carton

FUNGI NAIL TOE AND FOOT  MS
zinc undecylenate undecylenic acid ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-174
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC UNDECYLENATE (ZINC UNDECYLENATE) ZINC UNDECYLENATE20 g  in 20 g
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID5 g  in 20 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN 
PROPYLPARABEN 
PETROLATUM 
MINERAL OIL 
CETOSTEARYL ALCOHOL 
POLYSORBATE 60 
PEG-150 DISTEARATE 
STEARETH-20 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55505-174-5020 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/01/2012
Labeler - Kramer Laboratories (122720675)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmecuticals001207208manufacture

Revised: 10/2011
 
Kramer Laboratories