FUNGOID TINCTURE- miconazole nitrate tincture 
Pedinol Pharmacal, 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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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 15-30oC (59-86oF)

Inactive ingredients

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

Questions or comments?

1-800-321-4576

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)

Pedinol carton
FUNGOID TINCTURE 
miconazole nitrate tincture
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0884-0293
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Acetic Acid (UNII: Q40Q9N063P)  
Benzyl Alcohol (UNII: LKG8494WBH)  
Isopropyl Alcohol (UNII: ND2M416302)  
Laureth-4 (UNII: 6HQ855798J)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0884-0293-011 in 1 CARTON04/11/2012
129.57 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/11/2012
Labeler - Pedinol Pharmacal, Inc. (064737125)
Establishment
NameAddressID/FEIBusiness Operations
EMS Acquisition Corp.048602791MANUFACTURE(0884-0293)

Revised: 5/2020
Document Id: 5a414cfc-14d4-453a-8cef-ebe675f0153b
Set id: 250d0a66-01d1-4aba-8f24-4cb4ca529fda
Version: 7
Effective Time: 20200518
 
Pedinol Pharmacal, Inc.