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Fungoid Tincture Treatment Kit

Dosage form: kit
Ingredients: MICONAZOLE NITRATE 20mg in 1mL;
Labeler: Pedinol Pharmacal, Inc.
NDC Code: 0884-5493

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.

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

Principal Display Panel – Nail Scrub Label

0884-4891-02

PEDiNOL™

nail scrub™

nail rejuvenating,

cleansing & bleaching

agent

net wt. 2 oz. (56.7g)

Established Pharmacological Class
SubstancePharmacological Class
nail scrubOther Manicuring Preparations
FUNGOID TINCTURE TREATMENT KIT 
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0884-5493
Packaging
#Item CodePackage Description
1NDC:0884-5493-011 KIT in 1 CARTON
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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ACETIC ACID 
BENZYL ALCOHOL 
ISOPROPYL ALCOHOL 
LAURETH-4 
WATER 
Packaging
#Item CodePackage Description
129.57 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/1994
Part 2 of 2
NAIL SCRUB 
cleanser
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
WATER 
CALCIUM CARBONATE 
MINERAL OIL 
GLYCERYL MONOSTEARATE 
CETYL ALCOHOL 
POLYSORBATE 60 
SORBITAN MONOSTEARATE 
PHENOXYETHANOL 
SODIUM HYPOCHLORITE 
METHYLPARABEN 
DIAZOLIDINYL UREA 
PROPYLPARABEN 
EDETATE TRISODIUM 
SODIUM BENZOATE 
Packaging
#Item CodePackage Description
156.7 g in 1 BOTTLE
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 finalpart333C01/01/1994
Labeler - Pedinol Pharmacal, Inc. (064737125)
Establishment
NameAddressID/FEIOperations
EMS Contract Packaging048602791MANUFACTURE(0884-5493)

 
Pedinol Pharmacal, Inc.

Medically reviewed on Apr 26, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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