NDC | 49348-790-72 |
Set ID | fd853928-05e1-4db9-bb1d-6e6e6eaec7ed |
Category | HUMAN OTC DRUG LABEL |
Packager | McKesson |
Generic Name | |
Product Class | Allylamine Antifungal |
Product Number | |
Application Number | ANDA077511 |
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- 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
For external use only
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.
- Directions
- adults and children 12 years and older
- use the tip of the cap to break the seal and open the tube
- wash the affected skin with soap and water and dry completely before applying
- for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
- between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor.
- on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.
- for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor.
- wash hands after each use
- children under 12 years: ask a doctor
1 week between the toes
2 weeks on the bottom or sides of the foot - adults and children 12 years and older
- Other information
- do not use if seal on tube is broken or is not visible
- store at controlled room temperature 20°-25°C (68°-77°F)
- see carton or tube crimp for lot number and expiration date
- Inactive ingredients
benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.
Close - SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
sunmark®
athlete's foot cream
terbinafine hydrochloride cream 1%
antifungal cream
FULL PRESCRIPTION STRENGTH
NET WT 1 oz (30 g)
- INGREDIENTS AND APPEARANCE
ATHLETES FOOT
terbinafine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-790 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine Hydrochloride 1 g in 100 g Inactive Ingredients Ingredient Name Strength benzyl alcohol (UNII: LKG8494WBH) cetyl alcohol (UNII: 936JST6JCN) cetyl palmitate (UNII: 5ZA2S6B08X) isopropyl myristate (UNII: 0RE8K4LNJS) polysorbate 60 (UNII: CAL22UVI4M) water (UNII: 059QF0KO0R) sodium hydroxide (UNII: 55X04QC32I) sorbitan monostearate (UNII: NVZ4I0H58X) stearyl alcohol (UNII: 2KR89I4H1Y) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-790-72 1 in 1 CARTON 1 30 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077511 07/02/2007 Labeler - McKesson (177667227) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(49348-790)