Label: FORTICEPT ANTIFUNGAL COOLING- clotrimazole liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 52261-0502-0, 52261-0502-1 - Packager: Cosco International, 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 May 4, 2016
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- Official Label (Printer Friendly)
- Active Ingredient/Purpose
- Warnings
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Directions
- Wash affected area and dry thoroughly
- Spray 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 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
- SPL UNCLASSIFIED SECTION
- Inactive ingredients:
- 60g
- 120g
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INGREDIENTS AND APPEARANCE
FORTICEPT ANTIFUNGAL COOLING
clotrimazole liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52261-0502 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 g in 1000 g Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) 858.5 g in 1000 g glycerin (UNII: PDC6A3C0OX) 20 g in 1000 g dimethicone (UNII: 92RU3N3Y1O) 20 g in 1000 g oat (UNII: Z6J799EAJK) 15 g in 1000 g C14-22 Alcohols (UNII: B1K89384RJ) 15 g in 1000 g DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) 10 g in 1000 g sunflower oil (UNII: 3W1JG795YI) 10 g in 1000 g polydextrose (UNII: VH2XOU12IE) 10 g in 1000 g polihexanide hydrochloride (UNII: 4XI6112496) 10 g in 1000 g HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.s at 1%) (UNII: 86FQE96TZ4) 3.4 g in 1000 g isohexadecane (UNII: 918X1OUF1E) 3.3 g in 1000 g polysorbate 60 (UNII: CAL22UVI4M) 3.3 g in 1000 g lavender oil (UNII: ZBP1YXW0H8) 3 g in 1000 g CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 3 g in 1000 g PHYTATE SODIUM (UNII: 88496G1ERL) 2 g in 1000 g eucalyptus oil (UNII: 2R04ONI662) 2 g in 1000 g Tea Tree oil (UNII: VIF565UC2G) 1.5 g in 1000 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52261-0502-0 60 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/04/2016 2 NDC:52261-0502-1 120 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/04/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 05/04/2016 Labeler - Cosco International, Inc. (016433141) Registrant - Cosco International, Inc. (016433141) Establishment Name Address ID/FEI Business Operations Cosco International, Inc. 016433141 manufacture(52261-0502) , label(52261-0502) , pack(52261-0502)
