LOTRIMIN ANTIFUNGAL- 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 jock itch - relieves itching, burning, scaling, chafing and discomfort associated with jock itch

Authorization status:

OTC monograph final

Summary of Product characteristics

LOTRIMIN ANTIFUNGAL- 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._
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LOTRIMIN AF JOCK ITCH CREAM
_DRUG FACTS_
ACTIVE INGREDIENT
Clotrimazole 1%
PURPOSE
Antifungal
USES
cures most jock itch
relieves itching, burning, scaling, chafing and discomfort associated
with jock itch
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 2 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 over affected area twice daily (morning and night)
supervise children in the use of this product
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?
1-866-360-3266
Distributed by Bayer HealthCare LLC, Whippany, NJ, USA, 07981
PRINCIPAL DISPLAY PANEL - 12G TUBE CARTON
LOTRIMIN AF
ANTIFUNGAL
CLOTRIMAZOLE CREAM
NET WT 12G (0.42 OZ)
LOTRIMIN ANTIFUNGAL
clotrimazole cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:11523-1125
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)
CLOTRIMAZ OLE
10 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL ESTERS WAX (UNII: D072FFP9GU)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYSORBATE 60 (UN