FDA
Terbinafine Hydrochloride
The FDA lists this product in 17 strengths and forms.
Indications
Uses
- cures most athlete's foot (tinea pedis)
- cures most jock itch (tinea cruris) and ringworm (tinea corporis)
- relieves itching, burning, cracking and scaling which accompany these conditions
Warnings and precautions
Warnings For external use only Do not use
- on nails or scalp
- in or near the mouth or the eyes
- for vaginal yeast infections When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if
- too much irritation occurs or gets worse.
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Composition
- Active ingredients
- TERBINAFINE HYDROCHLORIDE 1%
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- TERBINAFINE HYDROCHLORIDE EQ 250MG BASE · TabletANDA076377-001 · Discontinued
- TERBINAFINE HYDROCHLORIDE EQ 250MG BASE · TabletANDA078229-001 · Discontinued
- TERBINAFINE HYDROCHLORIDE EQ 250MG BASE · TabletANDA077065-001 · Discontinued
- TERBINAFINE HYDROCHLORIDE EQ 250MG BASE · TabletANDA077195-001 · Discontinued
- TERBINAFINE HYDROCHLORIDE EQ 250MG BASE · TabletANDA077533-001 · Prescription
- TERBINAFINE HYDROCHLORIDE EQ 250MG BASE · TabletANDA077223-001 · Discontinued
At a glance
- Brand name
- Terbinafine Hydrochloride
- Route
- Topical
- Dosage form
- Cream
- Applicant
- Sun Pharma Canada
- Status
- Over the counter
- FDA approval
- 2 Jul 2007
- Application
- ANDA077511-001