Label: COLD SORE FEVER BLISTER TREATMENT- docosanol cream

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

Drug Label Information

Updated June 4, 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
    • 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 (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 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 the active ingredient in Abreva®

    Docosanol Cream, 10%

    Cold sore/fever blister treatment

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

    Portable convenient pump

    NET WT 2 g (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 GSK Consumer Healthcare, distributor of Abreva®.

    RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS

    DISTRIBUTED BY:

  • Package Label

    Docosanol 10%

    SIGNATURE SELECT Cold Sore Fever Blister Treatment

  • INGREDIENTS AND APPEARANCE
    COLD SORE FEVER BLISTER TREATMENT 
    docosanol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-605
    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:21130-605-072 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21238507/31/2024
    Labeler - Safeway, Inc. (009137209)
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