FUNGUS MD- tolnaftate liquid

FUNGUS MD by

Drug Labeling and Warnings

FUNGUS MD by is a Otc medication manufactured, distributed, or labeled by Orly International Inc, Private Label Partners, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

TOLNAFTATE 1%

PURPOSE

PURPOSE

ANTIFUNGAL

INDICATIONS & USAGE

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

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 OUT OF REACH OF CHILDREN

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

STOP USE

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGUS MD 
tolnaftate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69061-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69061-101-11	18 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	07/18/2014

Labeler - Orly International Inc (087181038)

Establishment
Name	Address	ID/FEI	Business Operations
Private Label Partners, Inc.		046033481	manufacture(69061-101)