DOCOSANOL cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DOCOSANOL (UNII: 9G1OE216XY) (DOCOSANOL - UNII:9G1OE216XY)
Available from:
Chain Drug Consortium, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Cold sore/fever blister treatment - treats cold sores/fever blisters on the face or lips - shortens healing time and duration of symptoms:                 • tingling, pain, burning, and/or itching -  if you are allergic to any ingredient in this product - your cold sore gets worse or the cold sore is not healed within 10 days
Authorization status:
Abbreviated New Drug Application
Authorization number:
68016-052-07

DOCOSANOL- docosanol cream

Chain Drug Consortium, LLC

----------

Docosanol Cream, 10%

Active ingredient

Docosanol 10%

Purpose

Cold sore/fever blister treatment

Uses

treats cold sores/fever blisters on the face or lips

shortens healing time and duration of symptoms:

tingling, pain, burning, and/or itching

Warnings

Allergy Alert

This product may cause a severe allergic reaction. Symptoms may include: hives facial swelling

wheezing/difficulty breathing shock rash

If an allergic reaction occurs, stop use and seek medical help right away.

For external use only

Do not use

if you are allergic to any ingredient in this product

When using this product

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.

Stop use and ask a doctor if

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Other information

store at 20° to 25°C (68° to 77°F)

do not freeze

Inactive ingredients

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

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday–Friday.

Docosanol Cream, 10%

Thank you for purchasing Docosanol Cream. We hope that since Docosanol Cream shortens the

healing time of cold sores, it helps you look and feel better faster. Please follow insert directions for

proper use and refer to the information below.

You are not alone

An estimated one-in-five Americans is affected by cold sores each year. Most people who experience

them get two to three cold sore outbreaks each year. Just before and during an outbreak, the cold sore

infection can be easily passed on to others. It is especially important to be aware of early warning signs

that a cold sore is coming, and to be sure to avoid close physical contact when you have one.

Getting to the Root of the Problem

A blister, or cluster of blisters around your mouth, is caused by the cold sore virus. After the cold sore

has healed, the virus stays dormant in your body but can be reactivated by everyday triggers like stress,

sunlight, extreme hot or cold weather, colds and flu, lack of sleep, or menstruation.

The Sooner, the Better

A typical cold sore outbreak can last as long as seven to ten days. The sooner you begin using

Docosanol Cream, the more effective the medicine will be. So for best results, use Docosanol Cream at

the very start of the cold sore - when you feel the first sign of the tingle, redness, bump or itch.

Docosanol Cream is different from other over-the-counter cold sore products. Only Docosanol Cream

contains 10% docosanol, which helps to shorten the healing time of cold sores and the duration of

symptoms including tingling, pain, itching and burning.

Frequently Asked Questions:

How is Docosanol Cream different from the over-the-counter cold sore remedies I have already

been using?

Docosanol Cream is a non-prescription cold sore medicine that can actually shorten healing time and the

duration of symptoms. The sooner you start using Docosanol Cream, the sooner you can begin healing

your cold sore.

Who can use Docosanol Cream?

Adults and children 12 years and over can use Docosanol Cream.

How often can I apply Docosanol Cream?

Docosanol Cream should be used five times a day until the cold sore is healed. Apply it directly to the

cold sore at the first sign of a tingle, redness, bump or itch for best results.

Can I apply cosmetics on top of Docosanol Cream?

Yes, cosmetics such as lipstick may be applied over Docosanol Cream. However, use a separate

applicator, like a cotton swab, to apply cosmetics over an unhealed cold sore to avoid spreading the

infection. For best results, remove any cosmetics prior to applying Docosanol Cream.

Made in the USA

Distributed by: Pharmacy Value Alliance, LLC

407 Lancaster Avenue, Wayne, PA 19087

Revised – March 2016

PRINCIPAL DISPLAY PANEL

Premier Value

COMPARE TO THE ACTIVE INGREDIENT IN ABREVA

Cold Sore / Fever Blister Treatment

Docosanol Cream, 10%

Non-prescription Medicine to Shorten Healing Time*

Cold Sore Treatment

For Topical Use Only

Net Wt. 2g (.07 oz)

®**

DOCOSANOL

docosanol cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 0 16 -0 52

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Chain Drug Consortium, LLC

Ingredient Name

Basis of Strength

Stre ng th

DO CO SANO L (UNII: 9 G1OE216 XY) (DOCOSANOL - UNII:9 G1OE216 XY)

DOCOSANOL

10 0 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SUCRO SE DISTEARATE (UNII: 33X4X4B9 0 S)

SUCRO SE STEARATE (UNII: 274KW0 O50 M)

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 0 16 -0 52-0 7

1 in 1 PACKAGE

0 4/0 2/20 19

1

2 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 8 754

0 4/0 2/20 19

Labeler -

Chain Drug Consortium, LLC (101668460)

Revised: 11/2019

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