Label: ATHLETES FOOT- terbinafin hydrochloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 11673-401-04 - Packager: Target Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated August 19, 2009
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use
- on nails or scalp
- in or near the mouth or eyes
- for vaginal yeast infections
When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water
Stop use and ask a doctor if too much irritation occurs or gets worse
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
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Directions
- adults and children 12 years and over
- 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
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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
1 week between the toes
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- on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
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2 weeks on the bottom or sides of the foot
- 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
Other information
Store at controlled room temperature 20-25°C (68-77°F)
See crimp for lot number and expiration date
Do not use if seal on tube is broken or is not visible
Questions? call 1-800-452-0051 24 hours a day, 7 days a week
100% Quality Guaranteed 888.309.9030
- adults and children 12 years and over
- Inactive ingredients
- Primary Display Pane
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INGREDIENTS AND APPEARANCE
ATHLETES FOOT
terbinafin hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-401 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE HYDROCHLORIDE 10 mg in 1 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-401-04 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 NDA NDA020980 08/31/2009 Labeler - Target Corporation (006961700)