1MED CLOTRIMAZOLE 1% ANTIFUNGAL CREAM- clotrimazole 1% antifungal cream cream 
QYK BRANDS 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.

----------

1MED Clotrimazole 1% Antifungal Cream

Clotrimazole 1%

Antifungal

cures most athlete's foot, jock itch and ringworm

relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

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.

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

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

10 milligrams/gram per application

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

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

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

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

73750-095-0173750-095-05

1MED CLOTRIMAZOLE 1% ANTIFUNGAL CREAM 
clotrimazole 1% antifungal cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73750-095
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73750-095-1030 g in 1 TUBE; Type 0: Not a Combination Product01/01/2022
2NDC:73750-095-0515 g in 1 TUBE; Type 0: Not a Combination Product01/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2022
Labeler - QYK BRANDS LLC (081560441)
Registrant - QYK BRANDS LLC (081560441)
Establishment
NameAddressID/FEIBusiness Operations
QYK Western081560441label(73750-095)

Revised: 2/2022
Document Id: d7167f6f-927a-4e2c-e053-2995a90ae3a8
Set id: d7100682-5494-3ab9-e053-2a95a90a9357
Version: 3
Effective Time: 20220202
 
QYK BRANDS LLC