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Forticept Antifungal Balm

Dosage form: liquid
Ingredients: tolnaftate 10g in 1000g
Labeler: Cosco International, Inc.
NDC Code: 52261-0100

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.

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
  • 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.

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

FORTICEPT ANTIFUNGAL BALM 
tolmaftate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-0100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
tolnaftate (TOLNAFTATE) tolnaftate10 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
water415.7 g  in 1000 g
sunflower oil158.225 g  in 1000 g
dimethicone150 g  in 1000 g
DIHEPTYL SUCCINATE80 g  in 1000 g
glyceryl monostearate65 g  in 1000 g
GLYCERYL DIBEHENATE50 g  in 1000 g
peg-40 castor oil25 g  in 1000 g
polyglyceryl-10 oleate24.675 g  in 1000 g
POLIHEXANIDE HYDROCHLORIDE10 g  in 1000 g
methyl lactate, (-)-4 g  in 1000 g
tea tree oil2.5 g  in 1000 g
eucalyptus oil1.8 g  in 1000 g
GLYCERYL CAPRATE1.05 g  in 1000 g
ACACIA DECURRENS FLOWER1.05 g  in 1000 g
Packaging
#Item CodePackage Description
1NDC:52261-0100-030 g in 1 TUBE
2NDC:52261-0100-160 g in 1 TUBE
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/FEIOperations
Cosco International, Inc.016433141manufacture(52261-0100), label(52261-0100), pack(52261-0100)

 
Cosco International, Inc.

Medically reviewed on May 11, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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