DOCOSANOL by KROGER COMPANY / Aurohealth LLC / APL HEALTHCARE LIMITED DOCOSANOL cream

DOCOSANOL by

Drug Labeling and Warnings

DOCOSANOL by is a Otc medication manufactured, distributed, or labeled by KROGER COMPANY, Aurohealth LLC, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 (1-800-222-1222) 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° to 25°C (68° to 77°F).

do not freeze

Inactive ingredients

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

Questions or comments?

call 1-800-632-6900

Additional information

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

Retain insert for full product uses, directions and warnings.

DISTRIBUTED BY
THE KROGER CO., CINCINNATI, OHIO 45202
MADE IN INDIA
‡OUR PHARMACIST RECOMMENDED

Code: TS/DRUGS/58039/2020

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 the only FDA approved 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.

For more information:

Call us at 1-800-632-6900

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Label 10% (2 g Tube)

Docosanol Cream 10%
Cold Sore/Fever Blister Treatment
For Topical Use Only
NET WT 2 g (0.07 oz)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Square Blister Card Label 10% (2 g Tube)

NDC: 30142-286-02

Kroger®
health

COMPARE TO THE ACTIVE INGREDIENT
IN ABREVA® COLD SCORE CREAM†

Docosanol Cream 10%
Cold Sore/
Fever Blister
Treatment
Non-Prescription
Medicine to
Shorten
Healing Time*

COLD SORE TREATMENT
FOR TOPICAL USE ONLY

NET WT
0.07 oz (2 g)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Clamshell Blister Card label 10% (2 g Tube)

NDC: 30142-286-04

Kroger®
health

COMPARE TO THE ACTIVE INGREDIENT
IN ABREVA® COLD SCORE CREAM†

Docosanol Cream 10%
Cold Sore/
Fever Blister
Treatment                                      TWIN
Non-Prescription                             PACK
Medicine to
Shorten
Healing Time*

COLD SORE
TREATMENT
FOR TOPICAL
USE ONLY

NET WT 0.14 OZ
(4 g) (2 TUBES,
0.07 OZ
[2 g] EACH)

INGREDIENTS AND APPEARANCE

DOCOSANOL 
docosanol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-286
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: 30142-286-02	1 in 1 PACKAGE	06/26/2024
1		2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 30142-286-04	2 in 1 PACKAGE	06/26/2024
2		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	ANDA217090	06/26/2024

Labeler - KROGER COMPANY (006999528)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		878100017	ANALYSIS(30142-286) , MANUFACTURE(30142-286)