DOCOSANOL DOCOSANOL COSETTE PHARMACEUTICALS, INC. FDA Approved Uses • treats cold sores/fever blisters on the face or lips • shortens healing time and duration of symptoms: • tingling, pain, burning, and/or itching
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Substance Docosanol
Route
TOPICAL
Applications
ANDA215839

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Docosanol 10%
Inactive Ingredients
Inactive ingredients benzyl alcohol light mineral oil propylene glycol purified water sucrose distearate sucrose stearate
Strengths
10 %
Quantities
2216 count
Treats Conditions
Uses Treats Cold Sores Fever Blisters On The Face Or Lips Shortens Healing Time And Duration Of Symptoms Tingling Pain Burning And Or Itching
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOX
UPC
0307130353021
UNII
9G1OE216XY
Packaging

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 Image-2 Image-4

Package Descriptions
  • 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 Image-2 Image-4

Overview

Uses • treats cold sores/fever blisters on the face or lips • shortens healing time and duration of symptoms: • tingling, pain, burning, and/or itching

Indications & Usage

Uses • treats cold sores/fever blisters on the face or lips • shortens healing time and duration of symptoms: • tingling, pain, burning, and/or itching

Dosage & Administration

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

Warnings & Precautions
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
Purpose

Purpose Cold sore/fever blister treatment

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


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