FUNGUS MD- tolnaftate liquid 
Orly International Inc

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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ACTIVE INGREDIENTS

TOLNAFTATE 1%

PURPOSE

ANTIFUNGAL

Uses

Effective treatment of athlete’s foot, jock itch and ringworm. Not for relief of infected finger nails and toe nails or effective against bacteria or viruses.

Warnings For external use only. Avoid contact with the eyes. Do not use on children under 2 years of age unless directed by a doctor. 

Keep this and all drugs out of the reach of children.

If treating athlete’s foot and ringworm: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. If treating jock itch: If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor. If swallowed, get medical help or contact a Poison Control Center right away.

Directions Clean or wash 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 doctor. Supervise children in the use of this product. For athelete’s foot: Pay special attention to spaces between 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 / Ingrédients Inactifs / Ingredientes Inactivos Aqua/Water/ Eau, PEG-8, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Propylene Glycol, Cocamidopropyl Betaine, Octoxynol-9, Glyceryl Stearate, Hydroxyethylcellulose, Stearyl Alcohol, Cetyl Alcohol, Methylparaben, Propylparaben, Imidazolidinyl Urea, Triethanolamine.

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FUNGUS MD 
tolnaftate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69061-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
IMIDUREA (UNII: M629807ATL)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69061-101-1118 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/18/2014
Labeler - Orly International Inc (087181038)
Establishment
NameAddressID/FEIBusiness Operations
Private Label Partners, Inc.046033481manufacture(69061-101)

Revised: 7/2014
 
Orly International Inc