Label: DOCOSANOL cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 1, 2021

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

  • SPL UNCLASSIFIED SECTION

    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 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 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
  • 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 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • SPL UNCLASSIFIED SECTION

    Distributed by: H2-Pharma, LLC
    Montgomery, AL 36117

  • PRINCIPAL DISPLAY PANEL - 2 g Tube Package

    NDC 61269-981-35
    Compare to the active
    ingredient in Abreva®

    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)

    H2 pharma

    PRINCIPAL DISPLAY PANEL - 2 g Tube Package
  • INGREDIENTS AND APPEARANCE
    DOCOSANOL 
    docosanol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61269-981
    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:61269-981-351 in 1 PACKAGE06/29/2021
    12 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20875406/29/2021
    Labeler - H2-Pharma, LLC (028473634)