Label: TOPCARE COLD SORE TREATMENT- camphor, menthol, phenol, white petrolatum gel

  • 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 April 1, 2021

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  • Active ingredients

    Camphor 3.00%

    Menthol 1.00%

    Phenol 1.50%

    White Petrolatum 89.20%

  • Purpose

    Cold sore/fever blister treatment

    Skin Protectant

  • Uses

    •
    For treatment of cold sores/fever blisters on the face or lips
    •
    Temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters
    •
    Temporarily protects minor cuts, scrapes, burns, and sores
    •
    Helps prevent and temporarily protects chapped or cracked skin and lips
  • Warnings

    For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician.

    Allergy alert: Do not use if you are allergic to any of the ingredients in this product.

    When using this product

    avoid contact with eyes. Use only as directed.

    Stop use and consult a doctor if

    the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

  • Directions

    •
    Clean the affected area
    •
    Apply a small amount of this product to the affected area 1 to 3 times daily
    •
    Rub in gently
    •
    May be covered with a sterile bandage
    •
    Wash hands before and after applying cream
    •
    Do not share this product with anyone
    •
    Children under 12 years of age: ask a doctor
  • Other information

    store at room temperature

  • Inactive ingredients

    Eucalyptol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thymol, Tocopheryl Nicotinate

  • Questions or comments?

    Call us toll-free at 1-888-423-0139.

    Serious side effects associated with use of this product may be reported to this number.

  • Package/Label Principal Display Panel

    MAXIMUM STRENGTH

    CAMPHOR 3.00%, MENTHOL 1.00%, PHENOL 1.50%, WHITE PETROLATUM 89.20%

    Cold Sore Treatment

    Cold Sore/Fever Blister Treatment & Skin Protectant

    Temporary Relief of Pain & Discomfort

    Works on Contact

    Applies Clear

    WITH TEA TREE OIL

    OUR PHARMACISTS RECOMMEND

    PARABEN FREE

    PHTHALATE FREE

    SULFATE FREE

    NET WT 0.07 FL OZ (2.0 g)

    cold-sore-treatment
  • INGREDIENTS AND APPEARANCE
    TOPCARE COLD SORE TREATMENT 
    camphor, menthol, phenol, white petrolatum gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-418
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)30 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 g
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL15 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM892 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTOL (UNII: RV6J6604TK)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    THYMOL (UNII: 3J50XA376E)  
    TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-418-011 in 1 PACKAGE03/09/2020
    12 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/09/2020
    Labeler - Topco Associates LLC (006935977)
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