FUNGOID TINCTURE TREATMENT KIT- miconazole nitrate kit

Fungoid Tincture Treatment Kit by

Drug Labeling and Warnings

Fungoid Tincture Treatment Kit 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%

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

SPL UNCLASSIFIED SECTION

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 scrub™ 2 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)

INGREDIENTS AND APPEARANCE

FUNGOID TINCTURE TREATMENT KIT 
miconazole nitrate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0884-5493

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0884-5493-01	1 in 1 CARTON; Type 0: Not a Combination Product	01/01/1994

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 BOTTLE, WITH APPLICATOR	1 mL
Part 2	0 BOTTLE	1 g

Part 1 of 2

FUNGOID TINCTURE 
miconazole nitrate tincture

Product Information
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		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

Part 2 of 2

NAIL SCRUB 
other manicuring preparations

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	CALCIUM CARBONATE (UNII: H0G9379FGK)
INGR	MINERAL OIL (UNII: T5L8T28FGP)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	POLYSORBATE 60 (UNII: CAL22UVI4M)
INGR	SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	EDETATE TRISODIUM (UNII: 420IP921MB)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		56.7 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/01/1994

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(0884-5493)