Formula# 39900

Formula# 39900
SPL v6
SPL
SPL Set ID 9dea4789-bf1c-1577-e053-2a95a90a5381
Route
TOPICAL
Published
Effective Date 2020-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Terbinafine (1 g)
Inactive Ingredients
Cetyl Palmitate Isopropyl Myristate Water Sodium Hydroxide Sorbitan Monostearate Cetyl Alcohol Polysorbate 60 Stearyl Alcohol Benzyl Alcohol

Identifiers & Packaging

Marketing Status
NDA Completed Since 2020-02-20 Until 2027-05-31

Description

Terbinafine hydrochloride 1%


Medication Information

Description

Terbinafine hydrochloride 1%

Uses

- cure most jock itch (tinea cruris) and ringworm (tinea corporis)

- relieves itching, burning, cracking andf scaling which accompany this condition

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if too much irritation occurs or gets worse

Section 50567-7

When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water

Section 50570-1

Do not use

- on nails or scalp

- in or near the mouth or eyes

- for vaginal yeast infections

Section 55105-1

Antifungal

Section 55106-9

Terbinafine hydrochloride 1%

Warnings

For external use only

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
  • 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

Other Information

- do no use if seal on tube is broken or is not visible

- store at controlled room temperature 20-25C (68-77F)

Inactive Ingredients

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearly alcohol

Questions Or Comments?

call 1-800-330-9876

12 G Tube With Carton for Jock Itch

Lamisil AT

Cream Terbinafine Hydrochloride Cream 1% - Antifungal

For JOCK ITCH

- cures most jock itch

- for effective relief of itching and burning

NET WT

12 g (0.42 oz)

12 G Tube With Carton for Athlete's Foot

Lamisil AT Cream

Terbinafine Hydrochloride Cream 1% - Antifungal

For Athlete's Foot

Net Wt

12 g (0.42 oz)

30 G Tube With Carton for Athlete's Foot

Lamisil AT Cream

Terbinafine Hydrochloride Cream 1% - Antifungal

For Athlete's Foot

NET WT

30 g (1 oz)


Structured Label Content

Uses

- cure most jock itch (tinea cruris) and ringworm (tinea corporis)

- relieves itching, burning, cracking andf scaling which accompany this condition

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if too much irritation occurs or gets worse

Section 50567-7 (50567-7)

When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water

Section 50570-1 (50570-1)

Do not use

- on nails or scalp

- in or near the mouth or eyes

- for vaginal yeast infections

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Terbinafine hydrochloride 1%

Warnings

For external use only

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
  • 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

Other Information

- do no use if seal on tube is broken or is not visible

- store at controlled room temperature 20-25C (68-77F)

Inactive Ingredients

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearly alcohol

Questions Or Comments? (Questions or comments?)

call 1-800-330-9876

12 G Tube With Carton for Jock Itch (12 g Tube with Carton - For Jock Itch)

Lamisil AT

Cream Terbinafine Hydrochloride Cream 1% - Antifungal

For JOCK ITCH

- cures most jock itch

- for effective relief of itching and burning

NET WT

12 g (0.42 oz)

12 G Tube With Carton for Athlete's Foot (12 g Tube with Carton - For Athlete's Foot)

Lamisil AT Cream

Terbinafine Hydrochloride Cream 1% - Antifungal

For Athlete's Foot

Net Wt

12 g (0.42 oz)

30 G Tube With Carton for Athlete's Foot (30 g Tube with Carton - For Athlete's Foot)

Lamisil AT Cream

Terbinafine Hydrochloride Cream 1% - Antifungal

For Athlete's Foot

NET WT

30 g (1 oz)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)