Forticept Antifungal Cooling (Clotrimazole) Liquid [Cosco International, Inc.] -

FORTICEPT ANTIFUNGAL COOLING (CLOTRIMAZOLE) LIQUID [COSCO INTERNATIONAL, INC.]
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NDC	52261-0502-0, 52261-0502-1
Set ID	e82e9521-6b0c-4b28-b64c-0cdfe97b320c
Category	HUMAN OTC DRUG LABEL
Packager	Cosco International, Inc.
Generic Name
Product Class	Azole Antifungal
Product Number
Application Number	PART333C

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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
- 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

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
120g

INGREDIENTS AND APPEARANCE

FORTICEPT ANTIFUNGAL COOLING
clotrimazole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52261-0502
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 g in 1000 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	05/04/2016

Labeler - Cosco International, Inc. (016433141)

Registrant - Cosco International, Inc. (016433141)

Name	Address	ID/FEI	Business Operations
Establishment
Cosco International, Inc.		016433141	manufacture(52261-0502) , label(52261-0502) , pack(52261-0502)

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Medic

FORTICEPT ANTIFUNGAL COOLING (CLOTRIMAZOLE) LIQUID [COSCO INTERNATIONAL, INC.]

Uses

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