ABREVA- docosanol cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOCOSANOL (UNII: 9G1OE216XY) (DOCOSANOL - UNII:9G1OE216XY)

Available from:

Haleon US Holdings LLC

INN (International Name):

DOCOSANOL

Composition:

DOCOSANOL 100 mg in 1 g

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 - tingling, pain, burning, and/or itching

Authorization status:

New Drug Application

Summary of Product characteristics

ABREVA- DOCOSANOL CREAM
HALEON US HOLDINGS LLC
----------
_DRUG FACTS_
_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 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 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 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
-25
C (68
-77
F)
do not freeze
_INACTIVE INGREDIENTS_
benzyl alcohol, light mineral oil, propylene glycol, purified water,
sucrose distearate,
sucrose stearate
_QUESTIONS OR COMMENTS?_
Call toll-free 1-877-709-3539
ADDITIONAL INFORMATION
*ABREVA CONTAINS THE ONLY OTC MEDICINE APPROVED BY THE FDA TO SHORTEN
HEALING TIME AND DURATION OF SYMPTOMS.
RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS.
If you are not completely satisfied, save receipt and remaining
product, and call us at 1-
877-709-3539.
Trademarks are owned by or licensed to the GSK group of companies.
Distributed for AVANIR PHARMACEUTICALSby
GSKCONSUMER HEALTHCARE
Warren, NJ 07059,