Label: CLOTRIMAZOLE 1% TOPICAL ANTIFUNGAL CREAM- clotrimazole 1% antifungal cream cream
- NDC Code(s): 73715-004-01
- Packager: Mohnark Pharmaceuticals Inc.
- 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.
Updated December 28, 2020
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- DRUG FACTS
- ACTIVE INGREDIENT
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 AND ASK DOCTOR IF
- 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
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- DOSAGE AND ADMINISTRATION
- INDICATIONS AND USAGE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE 1% TOPICAL ANTIFUNGAL CREAM
clotrimazole 1% antifungal cream cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73715-004 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:73715-004-01 28 g in 1 TUBE; Type 0: Not a Combination Product 12/21/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 12/21/2020 Labeler - Mohnark Pharmaceuticals Inc. (117013830) Establishment Name Address ID/FEI Business Operations Mohnark Pharmaceuticals Inc. 117013830 manufacture(73715-004)