{"active_ingredient":["ACTIVE INGREDIENT(S) Docosanol 10%"],"do_not_use":["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."],"dosage_and_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"],"effective_time":"20250908","id":"a1fe87d9-27cf-4ff0-9e70-52b038882e36","inactive_ingredient":["INACTIVE INGREDIENTS benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate and sucrose stearate"],"indications_and_usage":["USE(S) 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":["KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["ANDA212385"],"brand_name":["Docosanol"],"generic_name":["DOCOSANOL"],"is_original_packager":[true],"manufacturer_name":["Encube Ethicals, Inc."],"package_ndc":["21922-023-18","21922-023-17"],"product_ndc":["21922-023"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["797534"],"spl_id":["a1fe87d9-27cf-4ff0-9e70-52b038882e36"],"spl_set_id":["5b3137d3-c186-4c5d-89d2-ec5d1c3da8cd"],"substance_name":["DOCOSANOL"],"unii":["9G1OE216XY"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL For Pump Bottle - Carton Label NDC 21922-023-17 DOCOSANOL 10% CREAM Cold Sore/Fever Blister Treatment Only FDA Approved to Shorten Healing Time* Cold Sore Treatment NET WT 2g (0.07oz) For Pump Bottle - Bottle Label NDC 21922-023-17 DOCOSANOL 10% CREAM Cold Sore/Fever Blister Treatment Only FDA Approved to Shorten Healing Time* Cold Sore Treatment NET WT 2g (0.07oz) For Tube - Carton NDC 21922-023-18 DOCOSANOL 10% CREAM Cold Sore/Fever Blister Treatment Only FDA Approved to Shorten Healing Time* Cold Sore Treatment NET WT 2g (0.07 oz) For Tube NDC 21922-023-18 DOCOSANOL 10% CREAM Cold Sore/Fever Blister Treatment Only FDA Approved to Shorten Healing Time* Cold Sore Treatment NET WT 2g (0.07 oz) draft-pump-bottle-carton-label draft-pump-bottle-carton-label-Panel-1 draft-pump-bottle-carton-label-Panel-2-3 draft-pump-bottle-carton-label-Panel-4 draft-pump-bottle-label draft-tube-carton-label draft-tube-carton-label-Panel-1 draft-tube-carton-label-Panel-2-3 draft-tube-carton-label-Panel-4 draft-tube-label"],"purpose":["PURPOSE Cold sore/fever blister treatment"],"set_id":"5b3137d3-c186-4c5d-89d2-ec5d1c3da8cd","spl_product_data_elements":["Docosanol Docosanol DOCOSANOL DOCOSANOL BENZYL ALCOHOL LIGHT MINERAL OIL PROPYLENE GLYCOL WATER SUCROSE DISTEARATE SUCROSE STEARATE"],"spl_unclassified_section":["QUESTIONS OR COMMENTS? call toll-free 1-833-285-4151 from Monday to Friday between 9 am to 6.30 pm Manufactured by: Encube Ethicals Private Limited Plot No. C1,Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa – 403 404, India Distributed by: Encube Ethicals, Inc. 200 Meredith Avenue, Suite 101A Durham, NC 27713, USA Thank you for purchasing Docosanol Cream, 10%. 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, 10%, the more effective the medicine will be. So for best results, use Docosanol Cream, 10% at the very start of the cold sore - when you feel the first sign of the tingle, redness, bump or itch. Docosanol Cream, 10% is different from other over-the-counter cold sore products. Only Docosanol Cream, 10% 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: For Pump Bottle How to use your Docosanol Cream, 10% Pump - Adults and children 12 years and over can use Docosanol Cream, 10%. - Docosanol Cream, 10% 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. - If you wish, you can apply cosmetics such as lipstick over Docosanol Cream, 10%. 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, 10%. Press Pump completely about 6-8 times to get first dose. STEP 1 – Wash your hands before and after treating the cold sore. STEP 2 – Remove cap and press pump firmly. When first used, expect to press pump completely about 6-8 times before obtaining first dose. STEP 3 – Rub in gently but completely 5 times a day until healed for maximum of 10 days. STEP 4 – Place cap back on pump after each use. Steps For Tube Who can use Docosanol Cream, 10%? Adults and children 12 years and over can use Docosanol Cream, 10%. How often can I apply Docosanol Cream, 10%? Docosanol Cream, 10% 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, 10%? Yes, cosmetics such as lipstick may be applied over Docosanol Cream, 10%. 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, 10%."],"stop_use":["STOP USE AND ASK DOCTOR IF your cold sore gets worse or the cold sore is not healed within 10 days"],"storage_and_handling":["STORAGE store at 20°-25°C (68°-77°F) do not freeze"],"version":"2","warnings":["WARNINGS Allergy alert This product may cause a severe allergic reaction. Syptoms 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"]}