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

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

Section 55106-9

Terbinafine hydrochloride 1%


Structured Label Content

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

Warnings and Precautions (34071-1)

For external use only

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

Section 55106-9 (55106-9)

Terbinafine hydrochloride 1%


Raw Label Data

All Sections (JSON)