Forticept Antifungal Foot Gel

Forticept Antifungal Foot Gel
SPL v2
SPL
SPL Set ID 1b5851fc-ae73-4e54-bb62-3ff928628b97
Route
TOPICAL
Published
Effective Date 2020-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (0.01 kg)
Inactive Ingredients
Allantoin .alpha.-tocopherol Aluminum Starch Octenylsuccinate Benzethonium Chloride Cetostearyl Alcohol Ethylhexylglycerin Hexamethyldisilazane Isohexadecane Lanolin Mineral Oil Tea Tree Oil Peppermint Oil Petrolatum Phenoxyethanol Polihexanide Polysorbate 80 Propylene Glycol Shea Butter Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Steareth-2 Steareth-21 Thymol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-12

Description

Active Ingredient/Purpose Clotrimazole - 1% (Antifungal)


Medication Information

Indications and Usage

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

Description

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

Section 50565-1

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

Section 50567-7

When using this product avoid contact with eyes.

Section 50569-3

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).

Section 50570-1

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

Section 51945-4

Warnings:

For external use only!

Drug Facts

Active Ingredient/Purpose

Clotrimazole - 1% (Antifungal)

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

For Questions:

Please call: +1 212 709-8133

Lidan, Inc.

30 Wall Street, 8th Floor

New York, NY 10005

www.forticept.com

Other Information:

• To open: unscrew cap and remove the seal.

• Store between 68° - 77°F (20° - 25°C)

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


Structured Label Content

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

Indications and Usage (34067-9)

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

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

Section 50569-3 (50569-3)

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).

Section 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

Warnings: (WARNINGS:)

For external use only!

Drug Facts (DRUG FACTS)

Active Ingredient/Purpose

Clotrimazole - 1% (Antifungal)

Directions: (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

For Questions:

Please call: +1 212 709-8133

Lidan, Inc.

30 Wall Street, 8th Floor

New York, NY 10005

www.forticept.com

Other Information:

• To open: unscrew cap and remove the seal.

• Store between 68° - 77°F (20° - 25°C)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)