{"active_ingredient":["Active Ingredient Docosanol 10%"],"dosage_and_administration":["Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away."],"effective_time":"20251225","id":"439fd725-9dc5-4808-955f-1a855adb4cc7","inactive_ingredient":["Inactive ingredients benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate"],"indications_and_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"],"keep_out_of_reach_of_children":["Other information store at 20° to 25°C (68° to 77°F) do not freeze"],"openfda":{"application_number":["ANDA215839"],"brand_name":["Docosanol"],"generic_name":["DOCOSANOL"],"is_original_packager":[true],"manufacturer_name":["Leader/ Cardinal Health 110, Inc."],"package_ndc":["70000-0672-1","70000-0743-1"],"product_ndc":["70000-0672","70000-0743"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["797534"],"spl_id":["439fd725-9dc5-4808-955f-1a855adb4cc7"],"spl_set_id":["ed18ecb7-70ce-4037-a738-6b159e364d62"],"substance_name":["DOCOSANOL"],"unii":["9G1OE216XY"],"upc":["0096295143409","0096295145458"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL TUBE PACK NDC 70000-0672-1 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: CARDINAL HEALTH, DUBLIN, OHIO 43017 Code No.: GUJ/DRUGS/G/25/2216 Made in India PUMP PACK NDC 70000-0743-1 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: CARDINAL HEALTH, DUBLIN, OHIO 43017 Code No.: GUJ/DRUGS/G/25/2216 Made in India Tube Pack Pump Pack"],"purpose":["Purpose Cold sore/fever blister treatment"],"questions":["Questions or comments? Call 1-866-210-9797 Monday-Friday 9AM-6PM EST"],"set_id":"ed18ecb7-70ce-4037-a738-6b159e364d62","spl_product_data_elements":["Docosanol Docosanol DOCOSANOL DOCOSANOL BENZYL ALCOHOL LIGHT MINERAL OIL PROPYLENE GLYCOL WATER SUCROSE DISTEARATE SUCROSE STEARATE Docosanol Docosanol DOCOSANOL DOCOSANOL BENZYL ALCOHOL LIGHT MINERAL OIL PROPYLENE GLYCOL WATER SUCROSE DISTEARATE SUCROSE STEARATE"],"spl_unclassified_section":["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"],"version":"2","warnings":["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 produc 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"]}