Label: ZAPOTOL CLOTRIMAZOLE- clotrimazol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59428-359-28 - Packager: Zapotol Corp.
- 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 October 13, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Direction
- Wash affected area and dry thoroughly
- Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
- Supervise children in the use of this product
- For athlete's foot, pay special attention to spaces between the toes, wear well fitting ventilated shoes and change shoes and socks at least once a day
- 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
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ZAPOTOL CLOTRIMAZOLE
clotrimazol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59428-359 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg in 100 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PARAFFIN (UNII: I9O0E3H2ZE) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59428-359-28 1 in 1 CARTON 10/13/2016 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 08/07/2012 Labeler - Zapotol Corp. (186063850)