Label: FORTICEPT ANTIFUNGAL FOOT GEL- clotrimazole gel
- NDC Code(s): 72127-0806-0
- Packager: Lidan, 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.
Drug Label Information
Updated April 12, 2020
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- Official Label (Printer Friendly)
- DRUG FACTS
- Uses
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN
- DO NOT USE
- ASK DOCTOR
- WHEN USING
-
DIRECTIONS:
Adults and children 2 years of age and older:
• wash affected area and dry thoroughly
• apply a thin layer over affected area once or twice daily
• 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 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 -
Inactive Ingredients:
Allantoin, Alpha Tocopherol, Benzethonium Chloride, Cetosearyl Alcohol, Aluminum Starch Octenylsuccinate, Ethylhexylglycerin, Hexamethyldisilazane, Isohexadecane, Lanolin, Paraffinum Liquidum, Peppermint Oil, Petrolatum, Phenoxyethanol, Polyhexanide, Polysorbate 80, Propylene Glycol, Shea Butter, Sodium Acrylate / Sodium Acryloyldimethyl Taurate Copolymer, Steareth-2, Steareth-21, Tea Tree Oil, Thymol,
Water - Other Information:
- For Questions:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FORTICEPT ANTIFUNGAL FOOT GEL
clotrimazole gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72127-0806 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 0.01 kg in 1 kg Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) BENZETHONIUM CHLORIDE (UNII: PH41D05744) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXAMETHYLDISILAZANE (UNII: H36C68P1BH) ISOHEXADECANE (UNII: 918X1OUF1E) LANOLIN (UNII: 7EV65EAW6H) MINERAL OIL (UNII: T5L8T28FGP) TEA TREE OIL (UNII: VIF565UC2G) PEPPERMINT OIL (UNII: AV092KU4JH) PETROLATUM (UNII: 4T6H12BN9U) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLIHEXANIDE (UNII: 322U039GMF) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) Steareth-2 (UNII: V56DFE46J5) STEARETH-21 (UNII: 53J3F32P58) THYMOL (UNII: 3J50XA376E) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72127-0806-0 0.085 kg in 1 TUBE; Type 0: Not a Combination Product 04/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/12/2020 Labeler - Lidan, Inc. (014456716) Registrant - Lidan, Inc. (014456716) Establishment Name Address ID/FEI Business Operations Cosco International, Inc. 016433141 manufacture(72127-0806) , label(72127-0806) , pack(72127-0806) , api manufacture(72127-0806)
