FORTICEPT ANTIFUNGAL COOLING- clotrimazole liquid 
Cosco International, Inc.

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.

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Drug Facts

Active Ingredient/Purpose

Clotrimazole USP 1%........................Antifungal

Uses

  • cures most athlete’s foot infections (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) infections
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

For external use only

Do not use on children under 2 years of age unless direceted by a doctor.

When using this product avoid contact with eyes.

Stop use and ask a doctor if irritation occurs or 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.

Directions

Other Information  store between 20° - 25°C (68° - 77°F)

Inactive ingredients:

Aquaxyl, Dicaprylyl Carbonate, Dimethicone, Eucalyptus Oil, Glycerin, Lavender Oil, Montanov L, Oat Milk, Polyhexanide, Sepimax Zen, Simulgel INS100, Sodium Phytate, Sunflower Oil, Tea Tree Oil, Water

60g

60g

120g

120g

FORTICEPT ANTIFUNGAL COOLING 
clotrimazole liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-0502
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52261-0502-060 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2016
2NDC:52261-0502-1120 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/04/2016
Labeler - Cosco International, Inc. (016433141)
Registrant - Cosco International, Inc. (016433141)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc.016433141manufacture(52261-0502) , label(52261-0502) , pack(52261-0502)

Revised: 5/2016
Document Id: 789f1b3c-89e2-4dff-86a0-ca51b0a0a661
Set id: e82e9521-6b0c-4b28-b64c-0cdfe97b320c
Version: 1
Effective Time: 20160504
 
Cosco International, Inc.