FUNGOID TINCTURE TREATMENT KIT- miconazole nitrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)

Available from:

Pedinol Pharmacal, Inc.

INN (International Name):

MICONAZOLE NITRATE

Composition:

MICONAZOLE NITRATE 20 mg in 1 mL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Antifungal

Authorization status:

OTC monograph final

Summary of Product characteristics

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%
PURPOS E
Topical Antifungal
US ES
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WARNINGS
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KEEP OUT OF REACH OF CHILDREN
If swallowed, seek medical attention immediately.
DIRECTIONS
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®
cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
for effective relief of itchy, scaly skin between the toes
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.
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
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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 scrub
2 oz.
pedi-nail brush
store at controlled room temperature 15° - 30°C (59° - 86°F)
Protect from freezing. If freezing occurs, warm to room temperature.
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PRINCIPAL DISPLAY PANEL