FUNGOID TINCTURE TREATMENT KIT- miconazole nitrate 
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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Fungoid® Tincture Treatment Kit

Drug Facts

Active Ingredient

Miconazole Nitrate 2%

Purpose

Topical 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.

do not use on children under 2 yrs unless directed by a doctor.

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

KEEP OUT OF REACH OF CHILDREN

If swallowed, seek medical attention immediately.

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

Recommended Storage

store at controlled room temperature 15° - 30°C (59° - 86°F)
Protect from freezing. If freezing occurs, warm to room temperature.

Inactive Ingredients

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

Retain product insert for full directions and warnings

Questions or comments?

1-800-PEDiNOL (733-4665) or visit www.pedinol.com

Principal Display Panel – Kit Carton

NDC 0884-5493-01

PEDiNOL™

fungoid® tincture

treatment kit

miconazole nitrate 2%

topical antifungal

net contents:

fungoid® tincture 1 fl. oz.

nail scrub2 oz.

pedi-nail brush

Fungoid Tincture Treatment Kit Carton

Principal Display Panel – Nail Scrub Label

0884-4891-02

PEDiNOL™

nail scrub™

nail rejuvenating,

cleansing & bleaching

agent

net wt. 2 oz. (56.7g)

Nail-Scrub-2oz-Label
FUNGOID TINCTURE TREATMENT KIT 
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0884-5493
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0884-5493-011 in 1 CARTON; Type 0: Not a Combination Product01/01/199412/31/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 10 BOTTLE, WITH APPLICATOR 1 mL
Part 20 BOTTLE 1 g
Part 1 of 2
FUNGOID TINCTURE 
miconazole nitrate tincture
Product Information
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
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 finalpart333C01/01/1994
Part 2 of 2
NAIL SCRUB 
other manicuring preparations
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRCALCIUM CARBONATE (UNII: H0G9379FGK)  
INGRMINERAL OIL (UNII: T5L8T28FGP)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGRSORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRSODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGRDIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
INGREDETATE TRISODIUM (UNII: 420IP921MB)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
156.7 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/01/1994
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/199412/31/2018
Labeler - Pedinol Pharmacal, Inc. (064737125)
Establishment
NameAddressID/FEIBusiness Operations
EMS Contract Packaging048602791MANUFACTURE(0884-5493)

Revised: 12/2018
 
Pedinol Pharmacal, Inc.