FORTICEPT ANTIFUNGAL BALM- tolmaftate 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

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

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

30g

60g

60g

FORTICEPT ANTIFUNGAL BALM 
tolmaftate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-0100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
tolnaftate (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) tolnaftate10 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
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
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52261-0100-030 g in 1 TUBE; Type 0: Not a Combination Product05/04/2016
2NDC:52261-0100-160 g in 1 TUBE; 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(52261-0100) , label(52261-0100) , pack(52261-0100)

Revised: 5/2016
Document Id: 9987f223-4261-43a1-99d0-9219140c8c8a
Set id: ec71e0cb-37c7-42ff-a942-fe69af2eb92a
Version: 5
Effective Time: 20160511
 
Cosco International, Inc.