DOCOSANOL by Cosette Pharmaceuticals, Inc. / Alembic Pharmaceuticals Limited DOCOSANOL cream

DOCOSANOL by

Drug Labeling and Warnings

DOCOSANOL by is a Otc medication manufactured, distributed, or labeled by Cosette Pharmaceuticals, Inc., Alembic Pharmaceuticals Limited. 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 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 or comments?

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

Principal Display Panel

Tube Pack

NDC: 0713-0353-02

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

Distributed by:

Cosette Pharmaceuticals, Inc.

South Plainfield, NJ 07080

Made in India.

Code No.: GUJ/DRUGS/G/25/2216

2

Pump Pack

NDC: 0713-0353-62

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

Distributed by:

Cosette Pharmaceuticals, Inc.

South Plainfield, NJ 07080

Made in India.

Code No.: GUJ/DRUGS/G/25/2216

4

INGREDIENTS AND APPEARANCE

DOCOSANOL 
docosanol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0713-0353
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: 0713-0353-02	1 in 1 CARTON	01/04/2024
1		2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0713-0353-62	1 in 1 CARTON	01/04/2024
2		2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215839	01/04/2024

Labeler - Cosette Pharmaceuticals, Inc. (116918230)

Registrant - Alembic Pharmaceuticals Limited (650574663)

Establishment
Name	Address	ID/FEI	Business Operations
Alembic Pharmaceuticals Limited		871411532	MANUFACTURE(0713-0353) , ANALYSIS(0713-0353)