Search by Drug Name or NDC

NDC 71589-0019-03 DOCOSANOL 100 mg/g Details

DOCOSANOL 100 mg/g

DOCOSANOL is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Aleor Dermaceuticals Limited. The primary component is DOCOSANOL.

Product Information

NDC	71589-0019
Product ID	71589-019_79d7df50-7ce1-4679-b638-224ae611969c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	DOCOSANOL
Proprietary Name Suffix	n/a
Non-Proprietary Name	DOCOSANOL
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	100
Active Ingredient Units	mg/g
Substance Name	DOCOSANOL
Labeler Name	Aleor Dermaceuticals Limited
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA215839
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71589-0019-03 (71589001903)

Pricing Information	N/A
NDC Package Code	71589-019-03
Billing NDC	71589001903
Package	1 BOTTLE, PUMP in 1 PACKAGE (71589-019-03) / 2 g in 1 BOTTLE, PUMP
Marketing Start Date	2022-05-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 952520e5-dfc9-4946-941c-08560ce3d957 Details

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 ingredient

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

Questions or comments?

Call 1-866-210-9797 Monday-Friday 9AM-6PM EST

PRINCIPAL DISPLAY PANEL

Tube pack

NDC 71589-019-01

Docosanol Cream, 10%

Compare to the active ingredient in Abreva®**

Cold Sore/Fever Blister Treatment

Non-prescription Medicine to Shorten Healing Time*

Cold Sore Treatment

For Topical Use Only

NET WT 2g (0.07 oz)

**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.

*Contains the only non-prescription cold sore medicine approved by the FDA to shorten healing time and duration of symptoms.

RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS

Manufactured for:

Aleor Dermaceuticals Ltd.,

Karakhadi, Vadodara 391450, India.

PUMP PACK

NDC 71589-019-03