FORTICEPT ANTIFUNGAL FOOT GEL- clotrimazole gel

Forticept Antifungal Foot Gel by

Drug Labeling and Warnings

Forticept Antifungal Foot Gel by is a Otc medication manufactured, distributed, or labeled by Lidan, Inc., Cosco International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredient/Purpose

Clotrimazole - 1% (Antifungal)

Uses

Cures most athlete's foot, jock itch and ringworm
Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
Helps keep feet dry and free of fungal infection

For the treatment of fungal infections caused by: Athlete's foot (tinea pedis), Jock itch (tinea cruris), and Ringworm (tinea corporis)

WARNINGS:

For external use only!

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

DO NOT USE

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

ASK DOCTOR

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).

WHEN USING

When using this product avoid contact with eyes.

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:

To open: unscrew cap and remove the seal.
Store between 68° - 77°F (20° - 25°C)

For Questions:

Please call: +1 212 709-8133
Lidan, Inc.
30 Wall Street, 8th Floor
New York, NY 10005
www.forticept.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FORTICEPT ANTIFUNGAL FOOT GEL 
clotrimazole gel

Product 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)