Label: DOCOSANOL cream

  • NDC Code(s): 55301-112-07
  • Packager: AAFES/Your Military Exchanges
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 3, 2024

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  • 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

  • Principal display panel

    †Compare to active ingredient in Abreva®

    Docosanol Cream, 10%

    Cold sore/fever blister treatment

    • Only FDA approved medicine  to shorten healing time.*
    • Cold sore treatment

    NET WT 2g (0.07 OZ)

    *Docosanol Cream, 10% Contains the only OTC medicine approved by the FDA to shorten healing time and duration of symptoms.

    †This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Abreva®.

    RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS.

    Manufactured for Your Military Exchanges

    Distributed by:

    PL Developments

    200 Hicks Street

    Westbury, NY 11590

  • Package label

    Docosanol 10%

    EXCHANGE SELECT Cold Sore Fever Blister Treatment

  • INGREDIENTS AND APPEARANCE
    DOCOSANOL 
    docosanol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-112
    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:55301-112-071 in 1 PACKAGE12/31/2023
    12 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21238512/31/2023
    Labeler - AAFES/Your Military Exchanges (001695568)
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