Cvs

Drug Facts

Composition & Product

Active Ingredients

Terbinafine (1 g)

Inactive Ingredients

Benzyl Alcohol Cetyl Alcohol Cetyl Palmitate Isopropyl Myristate Polysorbate 60 Water Sodium Hydroxide Sorbitan Monostearate Stearyl Alcohol

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

ANDA Active Since 2007-07-02

Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses

cures most jock itch (tinea cruris)
relieves itching, burning, cracking and scaling which accompanies this condition

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a poison control center right away.

Section 50567-7

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

Warnings

For external use only

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 jock itchapply once a day (morning ornight) for 1 weekor as directed by a doctor.
- wash hands after each use
children under 12 years: ask a doctor

Do Not Use

on nails or scalp
in or near the mouth or the eyes
for vaginal yeast infections

Questions?

Call 1-866-923-4914

Active Ingredient

Terbinafine hydrochloride 1%

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.

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.

Principal Display Panel 15 G Tube Carton

CVSHealth _™

Compare to the active ingredient in Lamisil AT ^®*

NDC 59779-523-01

Full Prescription Strength

Jock Itch Cream

TERBINAFINE HYDROCHLORIDE CREAM 1%

Antifungal cream

NET WT .5 OZ (15 g)

Structured Label Content

Uses

cures most jock itch (tinea cruris)
relieves itching, burning, cracking and scaling which accompanies this condition

Section 42229-5 (42229-5)

Drug Facts

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 50567-7 (50567-7)

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

Purpose

Antifungal

Warnings

For external use only

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 jock itchapply once a day (morning ornight) for 1 weekor as directed by a doctor.
- wash hands after each use
children under 12 years: ask a doctor

Do Not Use (Do not use)

on nails or scalp
in or near the mouth or the eyes
for vaginal yeast infections

Questions?

Call 1-866-923-4914

Active Ingredient (Active ingredient)

Terbinafine hydrochloride 1%

Other Information (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 (Inactive ingredients)

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

Stop Use and Ask A Doctor If (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.

Principal Display Panel 15 G Tube Carton (PRINCIPAL DISPLAY PANEL - 15 g Tube Carton)

CVSHealth _™

Compare to the active ingredient in Lamisil AT ^®*

NDC 59779-523-01

Full Prescription Strength

Jock Itch Cream

TERBINAFINE HYDROCHLORIDE CREAM 1%

Antifungal cream

NET WT .5 OZ (15 g)

Advanced Ingredient Data

[{"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYL ALCOHOL", "unii": "936JST6JCN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYL PALMITATE", "unii": "5ZA2S6B08X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 60", "unii": "CAL22UVI4M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN MONOSTEARATE", "unii": "NVZ4I0H58X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARYL ALCOHOL", "unii": "2KR89I4H1Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TERBINAFINE", "unii": "G7RIW8S0XP", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "cures most jock itch (tinea cruris) relieves itching, burning, cracking and scaling which accompanies this condition", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.", "50567-7": "When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.", "Purpose": "Antifungal", "Warnings": "For external use only", "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 jock itch 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", "Do not use": "on nails or scalp in or near the mouth or the eyes for vaginal yeast infections", "Questions?": "Call 1-866-923-4914", "Active ingredient": "Terbinafine hydrochloride 1%", "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.", "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.", "PRINCIPAL DISPLAY PANEL - 15 g Tube Carton": "CVSHealth ™ Compare to the active ingredient in Lamisil AT ® * NDC 59779-523-01 Full Prescription Strength Jock Itch Cream TERBINAFINE HYDROCHLORIDE CREAM 1% Antifungal cream NET WT .5 OZ (15 g)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information