1MED CLOTRIMAZOLE 1% ANTIFUNGAL CREAM- clotrimazole 1% antifungal cream cream

1MED Clotrimazole 1% Antifungal Cream by

Drug Labeling and Warnings

1MED Clotrimazole 1% Antifungal Cream by is a Otc medication manufactured, distributed, or labeled by QYK BRANDS LLC, QYK Western. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Clotrimazole 1%

PURPOSE

Antifungal

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 eyes

Stop use and ask a doctor if

irritation occurs

there is no improvement within 4 weeks (for athlete's foot or 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.

STOP USE

irritation occurs
there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

INSTRUCTIONS FOR USE

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 the spaces between the toes, wear well fitting, ventilated shoes and change 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

DOSAGE & ADMINISTRATION

10 milligrams/gram per application

INACTIVE INGREDIENT

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

OTHER SAFETY INFORMATION

To open: unscrew cap, remove liner seal and replace cap
Store at USP controlled room temperature 20-25°C (68-77°F)
see carton or tube crimp for lot number and expiration date

INDICATIONS & USAGE

Adults and children 2 years and older: apply externally to the affected area twice a day (morning and night).
Children under 2 years of age: consult a doctor

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

1MED CLOTRIMAZOLE 1% ANTIFUNGAL CREAM 
clotrimazole 1% antifungal cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73750-095
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	69.5 g  in 100 g
POLYSORBATE 60 (UNII: CAL22UVI4M)	1.5 g  in 100 g
BENZYL ALCOHOL (UNII: LKG8494WBH)	1 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73750-095-10	30 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2022
2	NDC: 73750-095-05	15 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/2022

Labeler - QYK BRANDS LLC (081560441)

Registrant - QYK BRANDS LLC (081560441)

Establishment
Name	Address	ID/FEI	Business Operations
QYK Western		081560441	label(73750-095)