KAISER PERMANENTE MICONAZOLE NITRATE- 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:

Kaiser Foundation Hospitals

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antifungal - effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) - for effective relief of itching, scaling, burning and discomfort that can accompany these conditions.

Authorization status:

OTC monograph final

Summary of Product characteristics

KAISER PERMANENTE MICONAZOLE NITRATE- MICONAZOLE NITRATE CREAM
KAISER FOUNDATION HOSPITALS
_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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KAISER PERMANENTE
MICONAZOLE NITRATE
_DRUG FACTS_
ACTIVE INGREDIENT
Miconazole nitrate USP 2%
PURPOS E
Antifungal
US ES
effective in the treatment of most athlete's foot (tinea pedis), jock
itch (tinea cruris), and ringworm
(tinea corporis)
for effective relief of itching, scaling, burning and discomfort that
can accompany these conditions.
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE on children less than 2 years of age unless directed by a
doctor
WHEN USING THIS PRODUCT avoid contact with eyes
STOP USE AND ASK A DOCTOR IF
irritation occurs
condition persists
there is no improvement of athlete's foot or ringworm within 4 weeks
or jock itch within 2 weeks.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison Control Center right
away (1-800-222-1222).
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 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
not effective on the scalp or nails
®
OTHER INFORMATION
To open: unscrew cap, use pointed end on cap to puncture seal
store at 20° - 25°C (68° - 77°F)
see carton or tube crimp for lot number and expiration date
INACTIVE INGREDIENTS
apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil,
PEG-6, PEG-6-32 stearate, purified
water
QUES TIONS ?
Call 1-866-923-4914
Manufactured by
TARO PHARMACEUTICALS INC.
Brampton, Ontario, Canada L6T 1C1
Distributed by
KAISER FOUNDATION HO