Label: SHING-RELEEV- benzalkonium chloride liquid

  • 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 July 30, 2012

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  • ACTIVE INGREDIENTS:

    Benzalkanium Chloride .13%
    Allantoin .5%
    Benzyl Alcohol .5%
  • USES:

    For the relive of symtoms associated with shingles including pain, Burning, Itching and tingling First aid to help guard against secondary skin infection due to shingles.

  • WARNINGS:

    For external used only. Not for ingestion.

    Do not used- in yeast infections- do not spray directly on the eyes

    When using this product, may tingle on contact.

    Stop used and ask doctor if - condition worsens- symptoms

    last more then 7 days .

  • KEEP OUT OF REACH OF CHILDREN:


    If swallowget medical help or contact a Poison Control Center right away.






  • DIRECTIONS:

    Use at first sign of irritation or itching.

    Adults and children 12  years or older. Clean without soap.
    apply liberally to clean dry area free of soap or cleanser residue.
  • DOSAGE & ADMINISTRATION


    Apply to area as needed  3-4  times daily.
    Do not use cotton applicator.
    May be used with sterile bandage after area is dry.






  • Other Ingredients

    .Methylparaben Potassium Sorbate (natural preservative ).

    Propylparaben , Viracea (proprietary Echinacea purpurea extract),

    water (purified)

  • PRINCIPAL DISPLAY PANEL

    Shing carton

    Shing Carton approved

  • INGREDIENTS AND APPEARANCE
    SHING-RELEEV  
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63287-420
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mg  in 1 mL
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin5 mg  in 1 mL
    Benzyl Alcohol (UNII: LKG8494WBH) (Benzyl Alcohol - UNII:LKG8494WBH) Benzyl Alcohol5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Echinacea purpurea flowering top (UNII: 2EMS3QFX65)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63287-420-021 in 1 BOX
    1NDC:63287-420-0160 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/14/2010
    Labeler - Merix Pharmaceutical Corp. (158385687)
    Registrant - Topical Pharmaceutiocals Inc. (831530683)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topical Pharmaceutiocals Inc.831530683manufacture(63287-420)
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