Label: 1MED CLOTRIMAZOLE 1% ANTIFUNGAL CREAM- clotrimazole 1% antifungal cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 73750-091-05, 73750-091-10 - Packager: QYK BRANDS LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 4, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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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
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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
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
1MED CLOTRIMAZOLE 1% ANTIFUNGAL CREAM
clotrimazole 1% antifungal cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73750-091 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:73750-091-10 30 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2022 2 NDC:73750-091-05 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 081560441 label(73750-091)