Label: FUNGIFOAM- tolnaftate aerosol, foam
- NDC Code(s): 49406-004-30, 49406-004-75
- Packager: The Tetra Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated July 13, 2020
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- Active Ingredient
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 pregnant or breast-feeding
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:
- Inactive ingredients:
- Package Label
INGREDIENTS AND APPEARANCE
tolnaftate aerosol, foam
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49406-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETEARETH-25 (UNII: 8FA93U5T67) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) STEARIC ACID (UNII: 4ELV7Z65AP) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) JOJOBA OIL (UNII: 724GKU717M) TROLAMINE (UNII: 9O3K93S3TK) UREA (UNII: 8W8T17847W) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49406-004-75 1 in 1 BOX 07/13/2020 1 75 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49406-004-30 1 in 1 BOX 07/13/2020 2 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 07/13/2020 Labeler - The Tetra Corporation (829958409) Registrant - The Tetra Corporation (829958409) Establishment Name Address ID/FEI Business Operations Paket Corporation 007774730 manufacture(49406-004)