CLOTRIMAZOLE 1% TOPICAL ANTIFUNGAL CREAM- clotrimazole 1% antifungal cream cream 
Mohnark Pharmaceuticals Inc.

----------

DRUG FACTS

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

Keep out of reach of children.

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

STOP USE AND ASK DOCTOR IF

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

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

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

DOSAGE AND ADMINISTRATION

10 milligrams/gram per application

INDICATIONS AND 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

Clotrimazole 1% Carton

CLOTRIMAZOLE 1% TOPICAL ANTIFUNGAL CREAM 
clotrimazole 1% antifungal cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73715-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH) 1 g  in 100 g
WATER (UNII: 059QF0KO0R) 69.5 g  in 100 g
POLYSORBATE 60 (UNII: CAL22UVI4M) 1.5 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73715-004-0128 g in 1 TUBE; Type 0: Not a Combination Product12/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00512/21/2020
Labeler - Mohnark Pharmaceuticals Inc. (117013830)
Establishment
NameAddressID/FEIBusiness Operations
Mohnark Pharmaceuticals Inc.117013830manufacture(73715-004)

Revised: 1/2024
Document Id: 0fa95b2a-768b-ee79-e063-6294a90aa056
Set id: b3b83f3f-9349-fb75-e053-2995a90acb65
Version: 4
Effective Time: 20240123
 
Mohnark Pharmaceuticals Inc.