Docosanol by Actavis Pharma, Inc. DOCOSANOL cream

Docosanol by

Drug Labeling and Warnings

Docosanol by is a Otc medication manufactured, distributed, or labeled by Actavis Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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: Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Revised – March 2016

PRINCIPAL DISPLAY PANEL

Actavis

NDC 0591-2981-35

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. 2g (.07 oz)

INGREDIENTS AND APPEARANCE

DOCOSANOL 
docosanol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0591-2981
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCOSANOL (UNII: 9G1OE216XY) (DOCOSANOL - UNII:9G1OE216XY)	DOCOSANOL	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SUCROSE DISTEARATE (UNII: 33X4X4B90S)
SUCROSE STEARATE (UNII: 274KW0O50M)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0591-2981-35	1 in 1 PACKAGE	04/05/2019
1		2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208754	04/05/2019

Labeler - Actavis Pharma, Inc. (119723554)

Establishment
Name	Address	ID/FEI	Business Operations
Actavis Laboratories UT, Inc.		079589880	LABEL(0591-2981) , MANUFACTURE(0591-2981) , PACK(0591-2981)