VIRCIN ADVANCED WART TREATMENT (SALICYLIC ACID) CREAM [PURE SOURCE, LLC]

VIRCIN ADVANCED WART TREATMENT (SALICYLIC ACID) CREAM [PURE SOURCE, LLC]
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NDC 65121-397-15
Set ID 09e28a7d-9b89-4b97-bfab-111bdc025299
Category HUMAN OTC DRUG LABEL
Packager Pure Source, LLC
Generic Name
Product Class
Product Number
Application Number PART358B
  • Active Ingredient

    Salicylic acid 17%; in collodion; contains alcohol

  • Purpose

    Wart Remover

  • Uses:

    For the removal of plantar warts on the bottom of the foot. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern. For the removal of common warts. The common wart is easily recognized by the rough “cauliflower-like” appearance of the surface.

  • Warnings

    For external use only. Do not use on irritated skin, infected or reddened areas, moles, birthmarks, warts with hair growing from them, genital warts, warts on the face or mucous membrane. Ask a doctor before use if you have diabetes or poor blood circulation. Avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes. Avoid inhaling vapors. Stop use and ask a doctor if discomfort persists. Flammable. Keep away from fire and flame. Cap tube tightly and store at room temperature away from heat.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    Wash affected area, may soak in warm water for 5 minutes. Dry area thoroughly. By squeezing tube gently, apply one drop at a time to sufficiently cover each wart. Let dry. Repeat this procedure twice daily as needed (until wart is removed) for up to 12 weeks or as directed by a doctor.

  • Inactive Ingredients:

    BHT, Ethyl Pyruvate, Glycerin, Povidone Iodine, Propylene Glycol, Transcutol, Triethanolamine

  • VIRCIN Advanced wart treatment 0.5oz/14g (65121-397-15)

    VircinTube

    VircinBox

  • INGREDIENTS AND APPEARANCE
    VIRCIN ADVANCED WART TREATMENT 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-397
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID17 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ETHYL PYRUVATE (UNII: 03O98E01OB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE-IODINE (UNII: 85H0HZU99M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65121-397-151 in 1 CARTON02/10/2017
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B06/12/2014
    Labeler - Pure Source, LLC (080354456)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(65121-397)

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