Label: TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride cream
- NDC Code(s): 37205-941-99
- Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Terbinafine hydrochloride 1%Close
- 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
For external use only
When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
- 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
between the toes
2 weeks on the bottom
or sides of the foot
- 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
DUBLIN, OHIO 43017
- PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
CURES MOST ATHLETE'S FOOT
Athlete's Foot Cream
Terbinafine Hydrochloride Cream 1%
• GUARANTEED •
NET WT 1/2 oz (15 g)
- INGREDIENTS AND APPEARANCE
terbinafine hydrochloride cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-941 Route of Administration TOPICAL DEA Schedule 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:37205-941-99 1 in 1 CARTON 1 15 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 - Cardinal Health (097537435) Registrant - Taro Pharmaceuticals Inc. (206263295) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(37205-941)