LOTRIMIN- clotrimazole cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bayer HealthCare LLC

INN (International Name):

CLOTRIMAZOLE

Composition:

CLOTRIMAZOLE 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antifungal - cures most athlete's foot, jock itch, and ringworm - relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Authorization status:

OTC monograph final

Summary of Product characteristics

LOTRIMIN- CLOTRIMAZOLE CREAM
BAYER HEALTHCARE LLC
_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._
----------
LOTRIMIN
CLOTRIMAZOLE
_DRUG FACTS_
ACTIVE INGREDIENT
Clotrimazole 1%
PURPOSE
Antifungal
USES
cures most athlete's foot, jock itch, and ringworm
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 the eyes
STOP USE AND ASK A DOCTOR IF
irritation occurs
there is no improvement within 4 weeks (for athlete's foot and
ringworm) or 2 weeks
(for jock itch)
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 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
for athlete's foot and ringworm, use daily for 4 weeks; for jock itch,
use daily for 2
weeks
®
if condition persists longer, ask a doctor
this product is not effective on the scalp or nails
OTHER INFORMATION
store between 20° to 25°C (68° to 77°F)
INACTIVE INGREDIENTS
benzyl alcohol, cetyl alcohol, cetyl esters wax, octyldodecanol,
polysorbate 60, sorbitan
monostearate, stearyl alcohol, water
QUESTIONS?
866-360-3226
Distributed by Bayer HealthCare LLC, Whippany, NJ, USA, 07981
PRINCIPAL DISPLAY PANEL - 12 G TUBE CARTON
LOTRIMIN
AF
CLOTRIMAZOLE CREAM
ANTIFUNGAL
NET WT 12g (0.42 OZ)
LOTRIMIN
clotrimazole cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:11523-0963
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
®
INGREDIENT NAME
BASIS OF STRENGTH
STRENG