DB ANTIFUNGAL FOOT- miconazole nitrate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

The Magni Group Inc

INN (International Name):

MICONAZOLE NITRATE

Composition:

MICONAZOLE NITRATE 20 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

• Cures most tinea pedis (athlete’s foot) • Relieves itching, scaling, cracking, burning, redness; itchy, scaly skin between toes; itching, burning feet; discomfort

Authorization status:

OTC monograph final

Summary of Product characteristics

DB ANTIFUNGAL FOOT- MICONAZOLE NITRATE CREAM
THE MAGNI GROUP INC
----------
DB ANTIFUNGAL FOOT
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN CREAM)_
Miconazole Nitrate 2%
_PURPOSE_
Antifungal
_USES_
• Cures most tinea pedis (athlete’s foot) • Relieves itching,
scaling, cracking,
burning, redness; itchy, scaly skin between toes; itching, burning
feet; discomfort
_WARNINGS_
DO NOT USE
on children under 2 years of age unless directed by a doctor • For
external use only
Avoid contact with the eyes
If irritation occurs or if there is no improvement within 4 weeks,
discontinue use and
consult a doctor
KEEP OUT OF REACH OF CHILDREN
• If swallowed, get medical attention, help, or contact a poison
control center right away
_DIRECTIONS_
• Wash 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 the 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; for jock itch,
use daily for 2 weeks • If condition persists longer, consult a
doctor • This product is
not effective on the scalp or nails
_INACTIVE INGREDIENTS_
Allium Sativum Garlic (Plant) Extract, C12-15 Alkyl Benzoate,
Ceteth-20, Cetyl Alcohol,
Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Garcinia Indica Seed
Butter,
Hydroxyacetophenone, Isopropyl Palmitate, Isopropyl Myristate, Lemon
Oil, Melaleuca
Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Prunus Amygdalus
Dulcis (Sweet
Almond) Oil, Sodium Acrylate/Sodium Acryldimethyl Taurate Copolymer,
Tocopheryl
Acetate, Water
PACKAGE LABELING:
DB ANTIFUNGAL FOOT
miconazole nitrate cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:43689-0025
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
MICONAZOLE NITRATE (UNII: VW4H1