Label: COLD SORE FEVER BLISTER- docosanol cream

  • NDC Code(s): 30142-322-07, 30142-322-14
  • Packager: The Kroger Co.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 8, 2021

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

  • 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 1-800-632-6900

  • Principal display panel

    COMPARE TO active ingredient in Abreva®

    *See back panel

    Docosanol Cream 10%

    COLD SORE / FEVER BLISTER TREATMENT

    Cold Sore Treatment

    For Topical Use Only

    NON-PRESCRIPTION MEDICINE TO SHORTEN HEALING TIME**

    NET WT 2g (0.07 OZ)

    *This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.

    **Non-prescription cold sore medicine to shorten healing time and duration of symptoms.

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

    DISTRIBUTED BY

    THE KROGER CO.

    CINCINNATI, OHIO 45202

    www.kroger.com

  • Package label

    Docosanol 10%

    KROGER Cold Sore Fever Blister Treatment

  • INGREDIENTS AND APPEARANCE
    COLD SORE FEVER BLISTER 
    docosanol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-322
    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:30142-322-071 in 1 PACKAGE07/01/2020
    12 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:30142-322-142 in 1 PACKAGE07/01/2020
    22 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20875407/01/2020
    Labeler - The Kroger Co. (006999528)