FungiFoam description, usages, side effects, indications, overdosage, supplying and lots more!

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FungiFoam

The Tetra Corporation
Elba, Inc.

FungiFoam(R) ANTIFUNGAL


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Tolnaftate 1 percent

Purpose

Antifungal

Uses:

For effective treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis).
Relieves:

  • itching
  • scaling
  • cracking
  • redness
  • soreness
  • burning
  • irritation

Prevents the recurrence of most athlete's foot with daily use.

Warnings

For external use only.

When using this product avoid contact with the eyes.

Stop use and ask a doctor if:

  • When using for treatment of athlete's foot or ringworm: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
  • When using for prevention of athlete's foot: If irritation occurs, discontinue use and consult a doctor.

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding

ask a health professional before use.

Directions:

For treatment of athlete's foot, and ring-worm:

  • Clean the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.
  • 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 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. This product is not effective on the scalp or nails.

To prevent athlete's foot:

  • Wash the feet and dry thoroughly.
  • Apply a thin layer of the product to the feet once or twice daily (morning and/or night)
  • Supervise children in the use of this product.
  • Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.

Other information:

Store at room temperature, 25 degrees Celsius (77 degrees Fahrenheit).

Inactive ingredients:

BHT, C12-15 Alkyl Benzoate, Cellulose Gum, Ceteareth-20 and Ceteareth-25, Cetearyl Alcohol, Ehtyl-hexyglycerin, Ethoxydiglycol, Hydroxyethyl Cellulose, Stearic Acid, Phenoxyethanol, Polysorbate 60, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Triethanolamine, Urea and Water

Package Label


FungiFoam

FungiFoam

FungiFoam

TOLNAFTATE AEROSOL, FOAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49406-004
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Tolnaftate TOLNAFTATE 10 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
ALKYL (C12-15) BENZOATE
CARBOXYMETHYLCELLULOSE SODIUM
POLYOXYL 20 CETOSTEARYL ETHER
CETEARETH-25
CETOSTEARYL ALCOHOL
ETHYLHEXYLGLYCERIN
DIETHYLENE GLYCOL MONOETHYL ETHER
STEARIC ACID
PHENOXYETHANOL
POLYSORBATE 60
propylene glycol
Jojoba Oil
TROLAMINE
UREA
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 75 in 1 BOTTLE
2 NDC:49406-004-75 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2012-10-31


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