Label: DOCOSANOL cream

  • NDC Code(s): 58602-019-08, 58602-019-09, 58602-019-11, 58602-019-12, view more
    58602-019-13, 58602-019-15, 58602-019-16, 58602-019-17, 58602-019-24
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 2, 2024

If you are a consumer or patient please visit this version.

  • 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 toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

  • Additional information

    *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:                                            

    AUROHEALTH LLC,                                                         

    279 Princeton-Hightstown Road,

    East Windsor, NJ 08520                                              

    Made in India

    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.


    How to use your docosanol cream Pump (for pump pack)

    - For Adults and Children 12 years and older
    - 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.

    - If you wish, you can apply cosmetics such as lipstick 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.
    figure1
    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 to 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.

    For more information:


    Call us at 1-855-274-4122

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

    AUROHEALTH
    NDC 58602-019-07
    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 Label 10% (2 g Tube)
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Square Blister Card Label 10% (2 g Tube)

    AUROHEALTH
    #Compare to the active
    ingredient in Abreva®
    NDC 58602-019-08
    Docosanol Cream 10%
    Cold Sore/Fever Blister Treatment

    Non-Prescription Medicine to Shorten Healing Time*
    Cold Sore 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)
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Clamshell Blister Card label 10% (2 g Tube)

    AUROHEALTH
    #Compare to the active
    Ingredient in Abreva®
    NDC 58602-019-24
    Docosanol Cream 10%
    Cold Sore/Fever Blister Treatment

    Non-Prescription Medicine to Shorten Healing Time*
    Cold Sore Treatment
    For Topical Use Only
    NET WT 2 g (0.07 oz)


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

    AUROHEALTH
    NDC 58602-019-14
    Docosanol
    Cream 10%
    Cold Sore/
    Fever Blister
    Treatment
    For Topical Use Only

    NET WT 2 g
    (0.07 oz)


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

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

    AUROHEALTH
    #Compare to the active
    ingredient in Abreva®
    NDC 58602-019-15
    Docosanol Cream 10%
    Cold Sore/Fever Blister Treatment

    Non-Prescription Medicine to Shorten Healing Time*
    Portable
    Convenient
    Pump
    Cold Sore Treatment
    For Topical Use Only

    NET WT 2 g (0.07 oz)


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

    AUROHEALTH
    #Compare to the active
    Ingredient in Abreva®
    NDC 58602-019-16
    Docosanol Cream 10%
    Cold Sore/Fever Blister Treatment

    Non-Prescription Medicine to Shorten Healing Time*
    Portable
    Convenient
    Pump
    Cold Sore Treatment
    For Topical Use Only

    Read Inside fold out
    for full details

    NET WT
    2 g (0.07 oz)


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Pump Clamshell Blister Card Label 10% (2 g Pump)
  • INGREDIENTS AND APPEARANCE
    DOCOSANOL 
    docosanol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCOSANOL (UNII: 9G1OE216XY) (DOCOSANOL - UNII:9G1OE216XY) DOCOSANOL100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-019-081 in 1 PACKAGE03/01/2024
    12 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58602-019-241 in 1 PACKAGE03/01/2024
    22 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:58602-019-092 in 1 PACKAGE03/01/2024
    32 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:58602-019-111 in 1 PACKAGE03/01/2024
    43 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:58602-019-121 in 1 PACKAGE03/01/2024
    53 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:58602-019-132 in 1 PACKAGE03/01/2024
    63 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:58602-019-151 in 1 PACKAGE03/01/2024
    72 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    8NDC:58602-019-161 in 1 PACKAGE03/01/2024
    82 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    9NDC:58602-019-172 in 1 PACKAGE03/01/2024
    92 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21709003/01/2024
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED878100017ANALYSIS(58602-019) , MANUFACTURE(58602-019)