Forticept Antifungal Balm (Tolmaftate) Liquid [Cosco International, Inc.] -

FORTICEPT ANTIFUNGAL BALM (TOLMAFTATE) LIQUID [COSCO INTERNATIONAL, INC.]
PDF | XML

NDC	52261-0100-0, 52261-0100-1
Set ID	ec71e0cb-37c7-42ff-a942-fe69af2eb92a
Category	HUMAN OTC DRUG LABEL
Packager	Cosco International, Inc.
Generic Name
Product Class
Product Number
Application Number	PART333C

View All Sections

Active Ingredient/Purpose

Tolnaftate 1% w/w........................Antifungal

Uses

Proven clinically effective in the treatment and prevention of most athlete's foot (tinea pedis), ringworm (tinea corporis), and jock itch (tinea cruris).
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
- Read all package directions and warnings before use. Use only as directed.
- Clean the affected area with soap and warm water and dry thoroughly.
- Apply a thin layer of FORTICEPTTM COOLING BALM over the affected area twice daily (morning and night), or as directed by a doctor.
- For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
- For athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
- Intended for use by normally healthy individuals only.
- Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
- Supervise children in the use of this product.
SPL UNCLASSIFIED SECTION

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

Acticire®, Capric Caprylic Triglyceride, Dimethicone, Eucalyptus Oil, Glyceryl Behenate, Glyceryl Stearate, Lavender Oil, LexFeel® N5, Methyl Lactate, PEG 40 Hydrogenated Castor Oil, Polyhexanide, Sunflower Oil, Tea Tree Oil, Water
30g
60g

INGREDIENTS AND APPEARANCE

FORTICEPT ANTIFUNGAL BALM
tolmaftate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52261-0100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
tolnaftate (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	tolnaftate	10 g in 1000 g

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)	415.7 g in 1000 g
sunflower oil (UNII: 3W1JG795YI)	158.225 g in 1000 g
dimethicone (UNII: 92RU3N3Y1O)	150 g in 1000 g
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)	80 g in 1000 g
glyceryl monostearate (UNII: 230OU9XXE4)	65 g in 1000 g
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)	50 g in 1000 g
peg-40 castor oil (UNII: 4ERD2076EF)	25 g in 1000 g
polyglyceryl-10 oleate (UNII: 55C81W76DH)	24.675 g in 1000 g
POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)	10 g in 1000 g
methyl lactate, (-)- (UNII: 0379G9C44S)	4 g in 1000 g
tea tree oil (UNII: VIF565UC2G)	2.5 g in 1000 g
eucalyptus oil (UNII: 2R04ONI662)	1.8 g in 1000 g
GLYCERYL CAPRATE (UNII: 197M6VFC1W)	1.05 g in 1000 g
ACACIA DECURRENS FLOWER (UNII: 8PHF3LSM61)	1.05 g in 1000 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52261-0100-0	30 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2016
2	NDC:52261-0100-1	60 g in 1 TUBE; 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(52261-0100) , label(52261-0100) , pack(52261-0100)

View All Sections

Medic

FORTICEPT ANTIFUNGAL BALM (TOLMAFTATE) LIQUID [COSCO INTERNATIONAL, INC.]

Uses

Related Drugs