Quinsana Anti-Fungal Powder 2% Miconazole Nitrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Profoot Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- Cures most athlete’s foot and ringworm - Effectively relieves itching, cracking, and burning

Authorization status:

OTC monograph final

Summary of Product characteristics

QUINSANA ANTI-FUNGAL POWDER 2 MICONAZOLE NITRATE- MICONAZOLE
NITRATE POWDER
PROFOOT INC.
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QUINSANA ANTI-FUNGAL POWDER 2% MICONAZOLE NITRATE
_DRUG FACTS_
_ACTIVE INGREDIENT_
Miconazole Nitrate, 2%
_PURPOSE_
Antifungal
_USES_
Cures most athlete’s foot and ringworm
Effectively relieves itching, cracking, and burning
_WARNINGS_
FOR EXTERNAL USE ONLY
ASK A DOCTOR BEFORE USE
on children under 2 years of age
WHEN USING THIS PRODUCT
avoid contact with eyes
STOP USE AND ASK A DOCTOR IF
irritation occurs
there is no improvement within 4 weeks
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
Wash affected area and dry thoroughly.
Apply a thin layer of the product over affected area twice daily
(morning and night).
Supervise children in the use of this product.
For athlete’s foot: pay special attention to spaces between the
toes. Wear well-fitting,
ventilated shoes, and change shoes and socks at least once daily.
Use daily for 4 weeks; if condition persists longer, ask a doctor.
This product is not effective on the scalp or nails.
_INACTIVE INGREDIENTS_
Zea Mays (Corn) Starch, Tricalcium Phosphate, Microcrystalline
Cellulose,
Allantoin, Imidazolidinyl Urea, Chloroxylenol, Fragrance.
PACKAGE LABELING:
QUINSANA ANTI-FUNGAL POWDER 2 MICONAZOLE NITRATE
miconazole nitrate powder
Profoot Inc.
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:29784-145
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 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
STARCH, CORN (UNII: O8232NY3SJ)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ALLANTOIN (UNII: 344S277G0Z)
IMIDUREA (UNII: M629807ATL)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:29784-145-
85
85 g in 1 BOTTLE; Ty