FUNGOID TINCTURE- miconazole nitrate tincture

fungoid tincture by

Drug Labeling and Warnings

fungoid tincture by is a Otc medication manufactured, distributed, or labeled by Pedinol Pharmacal, Inc., EMS Contract Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Miconazole nitrate 2% USP

Purpose

Antifungal

Uses

• cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
• for effective relief of itchy, scaly skin between the toes

Warnings

For external use only

Flammable:

Do not use while smoking or near heat or flame.

Do not use

on children under 2 years of age unless directed by a doctor.

When using this product

• avoid contact with the eyes.
• If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

Keep out of reach of children.

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

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 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
• if condition persists longer, consult a doctor
• this product is not effective on scalp or nails.

Other information

• store at controlled room temperature 15o-30oC (59o-86oF)

Inactive ingredients

acetic acid, benzyl alcohol, isopropyl alcohol (30%), laureth-4, water

Questions or comments?

1-800-321-4576 or visit www.pedinol.com

Fungoid Tincture – 1 fl. oz. (29.57 mL) Carton

NDC 0884-0293-01

PEDiNOL®

fungoid® tincture

miconazole nitrate 2%

topical antifungal

1 fl. oz. (29.57 mL)

INGREDIENTS AND APPEARANCE

FUNGOID TINCTURE 
miconazole nitrate tincture

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0884-0293
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M)	Miconazole Nitrate	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Acetic Acid (UNII: Q40Q9N063P)
Benzyl Alcohol (UNII: LKG8494WBH)
Isopropyl Alcohol (UNII: ND2M416302)
Laureth-4 (UNII: 6HQ855798J)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0884-0293-01	1 in 1 CARTON	01/01/1994
1		29.57 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/1994

Labeler - Pedinol Pharmacal, Inc. (064737125)

Establishment
Name	Address	ID/FEI	Business Operations
EMS Contract Packaging		048602791	MANUFACTURE(0884-0293)