FORTINIA- clotrimazole 1% solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)

Available from:

The Podiatree Company

INN (International Name):

CLOTRIMAZOLE

Composition:

CLOTRIMAZOLE 1 g in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antifungal • cures most athlete’s foot infections and ringworm infections • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions on children under 2 years of age unless directed by a doctor. When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. • irritation occurs • there is no improvement within 4 weeks

Authorization status:

OTC monograph final

Summary of Product characteristics

FORTINIA- CLOTRIMAZOLE 1% SOLUTION
THE PODIATREE COMPANY
_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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ACTIVE INGREDIENT
Clotrimazole 1%
PURPOS E
Antifungal
US ES
• cures most athlete’s foot infections and ringworm infections
• relieves itching, burning, cracking, scaling and discomfort which
accompany these conditions
WARNINGS
For external use only
DO NOT USE
on children under 2 years of age unless directed by a doctor.
When using this product, avoid contact with eyes. If contact occurs,
rinse eyes thoroughly with water.
STOP USE AND ASK A DOCTOR OR PHARMACIST IF
• irritation occurs
• there is no improvement within 4 weeks
KEEP OUT OF REACH OF CHILDREN.
In case of accidental ingestion, seek medical help or contact a Poison
Control Center immediately.
DIRECTIONS
• wash affected area and dry thoroughly
• apply one drop to the affected area twice daily (morning and
night) or as directed by your doctor
• using a disposable cotton swab, spread a thin layer over the
affected area
• discard cotton swab
• 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 infections, use daily for 4
weeks
• this product is not effective on scalp or nails
OTHER INFORMATION
Store at controlled room temperature.
INACTIVE INGREDIENTS
Aloe barbadensis leaf extract, lavandula augustifolia (lavender) oil,
olea europaea (olive) leaf extract,
PEG 400, polysorbate 80, SD alcohol (9.75%), tocopheryl acetate
(Vitamin E), tritium vulgare (wheat)
germ oil
QUESTIONS OR SUGGESTIONS?
1.855.763.8733 or visit us at www.thepodiatreecompany.com
PRINCIPAL DISPLAY PANEL
Label
FORTINIA
clotrimazole 1% solution
The Podiatree Company
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE