Label: 3M NEXCARE COLD SORE TREATMENT- 3m nexcare cold sore treatment ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 15, 2010

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

  • SPL UNCLASSIFIED SECTION

    • Unique combination of ingredients
    • Helps relieve cold sore symptoms
    • Enriched with tea tree oil and Vitamin E
    • Helps get you back to living comfortably
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Active Ingredient

    Benzocaine, 5%

    Allantoin, 1%

    Purpose

    External analgesic

    Skin protectant

    Uses

    • temporarily relieves pain and itching associated with cold sores and fever blisters
    • relieves dryness and softens cold sores and fever blisters

    Warnings

    For external use only

    Do not use if you are allergic to any ingredient in this product

    When using this product do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

    Directions

    • adults and children 2 years of age and older:
    • apply directly to affected area with clean finger at the first sign of cold sore/fever blister (tingle)
    • apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a doctor

    Other information

    • store at 20-25°C{68-77°F)

    Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, butylated hydroxytoluene, cetyl alcohol, edetate disodium, ethyl oleate, ethylparaben, glycerin, melaleuca alternifolia (tea tree) leaf oil, menthol, methylparaben, phenoxyethanoi, poloxamer 185, propylparaben, propylene glycol monolaurate (Microvex™), sodium ascorbyl phosphate, sodium hydroxide, tocopheryl acetate, water

    Questions?

    Call 1-800-537-2191

    3M, Nexcare and Microvex
    are trademarks of 3M.

    3M Consumer Health Care
    3M Center
    St. Paul, MN 55144-1000
    www.nexcare.com

    Made in the U.S.A. for 3M from
    globally sourced materials.

    ©3M2008
    CAT#L116

    Patent Pending

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  • PRINCIPAL DISPLAY PANEL

    Package Label

    1 Tube

    NET WT 2g (0.07 oz)

    3M™ Nexcare™ Cold Sore Treatment

    Benzocaine 5%
    Allantoin 1 %

    Skin Protectant

    OTC Monograph

    3M Consumer Health Care, 3M Center, St. Paul, MN 55144-1000

    3M™ Nexcare™ Cold Sore Treatment - NET WT 2g (0.07 oz)

    3M™ Nexcare™ Cold Sore Treatment  - NET WT 2g (0.07 oz) - (front)
    3M™ Nexcare™ Cold Sore Treatment  - NET WT 2g (0.07 oz) - (back)
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  • INGREDIENTS AND APPEARANCE
    3M NEXCARE COLD SORE TREATMENT 
    3m nexcare cold sore treatment ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:17518-054
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 50 mg  in 1 g
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cetyl alcohol (UNII: 936JST6JCN)  
    edetate disodium (UNII: 7FLD91C86K)  
    ethyl oleate (UNII: Z2Z439864Y)  
    ethylparaben (UNII: 14255EXE39)  
    glycerin (UNII: PDC6A3C0OX)  
    menthol (UNII: L7T10EIP3A)  
    methylparaben (UNII: A2I8C7HI9T)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    propylene glycol monolaurate (UNII: M4AW13H75T)  
    sodium ascorbyl phosphate (UNII: 836SJG51DR)  
    sodium hydroxide (UNII: 55X04QC32I)  
    sucralose (UNII: 96K6UQ3ZD4)  
    water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17518-054-01 2 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 02/20/2008
    Labeler - 3M Company (006173082)
    Establishment
    Name Address ID/FEI Business Operations
    Celeste Contract Packaging 829739833 MANUFACTURE
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