principal display panel - 12 g tube carton

principal display panel - 12 g tube carton
SPL v1
SPL
SPL Set ID 3639d7f5-fee5-489c-9916-9a235d283830
Route
topical
Published
Effective Date 2020-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Drug Facts


Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Terbinafine hydrochloride 1%

Indications and Usage

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

Dosage and Administration

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 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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE. store at controlled room temperature 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date

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

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

Section 51727-6

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

Section 51945-4

Cures Most Jock Itch Full Prescription Strength Terbinafine Hydrochloride Cream 1% Antifungal NET WT 0.42 oz (12 g)

Section 53413-1

call 1-866-923-4914

Section 55105-1

Antifungal


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Terbinafine hydrochloride 1%

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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 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

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE. store at controlled room temperature 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date

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)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Cures Most Jock Itch Full Prescription Strength Terbinafine Hydrochloride Cream 1% Antifungal NET WT 0.42 oz (12 g)

Section 53413-1 (53413-1)

call 1-866-923-4914

Section 55105-1 (55105-1)

Antifungal


Raw Label Data

All Sections (JSON)