Principal Display Panel - 2 G Tube Package

Principal Display Panel - 2 G Tube Package
SPL v3
SPL
SPL Set ID a921a653-aedd-43c2-b84f-429a4aada79a
Route
TOPICAL
Published
Effective Date 2025-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Drug Facts


Medication Information

Indications and Usage

treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching

Dosage and Administration

adults and children 12 years or over: wash hands before and after applying cream apply to affected area on the face or lips at the first sign of cold sore/fever blister (tingle) early treatment ensures the best results rub in gently but completely use 5 times a day until healed children under 12 years: ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

store at 20° to 25°C (68° to 77°F) do not freeze

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

your cold sore gets worse or the cold sore is not healed within 10 days

Section 50567-7

apply only to the affected areas do not use in or near the eyes avoid applying directly inside your mouth do not share this product with anyone. This may spread the infection.

Section 50570-1

if you are allergic to any ingredient in this product

Section 51727-6

benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate

Section 51945-4

NDC 61269-981-35 † Compare to the active ingredient in Abreva ® Docosanol Cream 10% Cold sore/fever blister treatment Non-prescription medicine to shorten healing time* Cold sore treatment For topical use only Net wt. 2 g (0.07 oz) H 2 pharma

Section 53413-1

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Section 55105-1

Cold sore/fever blister treatment

Section 55106-9

Docosanol 10%


Structured Label Content

Indications and Usage (34067-9)

treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching

Dosage and Administration (34068-7)

adults and children 12 years or over: wash hands before and after applying cream apply to affected area on the face or lips at the first sign of cold sore/fever blister (tingle) early treatment ensures the best results rub in gently but completely use 5 times a day until healed children under 12 years: ask a doctor

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

store at 20° to 25°C (68° to 77°F) do not freeze

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)

your cold sore gets worse or the cold sore is not healed within 10 days

Section 50567-7 (50567-7)

apply only to the affected areas do not use in or near the eyes avoid applying directly inside your mouth do not share this product with anyone. This may spread the infection.

Section 50570-1 (50570-1)

if you are allergic to any ingredient in this product

Section 51727-6 (51727-6)

benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate

Section 51945-4 (51945-4)

NDC 61269-981-35 † Compare to the active ingredient in Abreva ® Docosanol Cream 10% Cold sore/fever blister treatment Non-prescription medicine to shorten healing time* Cold sore treatment For topical use only Net wt. 2 g (0.07 oz) H 2 pharma

Section 53413-1 (53413-1)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Section 55105-1 (55105-1)

Cold sore/fever blister treatment

Section 55106-9 (55106-9)

Docosanol 10%


Raw Label Data

All Sections (JSON)