Label: SHUNFA ANTI-BACTERIA SPRA- didecyldimethyl ammonium,triclosan, borneol, benzalkonium bromide spray

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated June 5, 2013

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  • ACTIVE INGREDIENTS

    Didecyldimethyl Ammonium 0.3%

    Triclosan                              0.3%

    Borneol                               0.4%

    Benzalkonium Bromide       0.3%

  • PURPOSES

    Antibacterial

  • KEEP OUT OF REACH OF CHILDREN.

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

  • DO NOT USE

    if you are allergic to any of the ingredients.

  • WHEN USING THIS DEVICE

    do not get into eyes. If eye contact occurs, rinse thoroughly with water.

  • STOP USE AND ASK A DOCTOR IF

    irritation or redness develops, and continues for more than 72 hours.

  • USES

    Uses spray to reduce bacteria on the skin.

  • WARNINGS

    For external use only.

  • DIRECTIONS

    for adults and children 2 years and olde, apply to human body, allow to dry without wiping, ask a doctor before using on children under 2 years.

  • INACTIVE INGREDIENTS

    Polyethylene Glycol, Menthol, Water

  • PRINCIPAL DISPLAY PANEL

    carton.jpg

  • INGREDIENTS AND APPEARANCE
    SHUNFA ANTI-BACTERIA SPRA 
    didecyldimethyl ammonium,triclosan, borneol, benzalkonium bromide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58686-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIDECYLDIMETHYLAMMONIUM (UNII: Z7F472XQPA) (DIDECYLDIMETHYLAMMONIUM - UNII:Z7F472XQPA) DIDECYLDIMETHYLAMMONIUM3 mg  in 1000 mg
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3 mg  in 1000 mg
    BENZALKONIUM BROMIDE (UNII: 151T1GQ42D) (BENZALKONIUM BROMIDE - UNII:151T1GQ42D) BENZALKONIUM BROMIDE3 mg  in 1000 mg
    BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X) BORNEOL4 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) 100 mg  in 1000 mg
    MENTHOL (UNII: L7T10EIP3A) 3 mg  in 1000 mg
    WATER (UNII: 059QF0KO0R) 800 mg  in 1000 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58686-013-0130 mg in 1 BOTTLE, SPRAY
    2NDC:58686-013-025 mg in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/30/2005
    Labeler - Chengdu Shunfa Disinfection and Washing Technology Co Ltd (527046468)
    Registrant - Chengdu Shunfa Disinfection and Washing Technology Co Ltd (527046468)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chengdu Shunfa Disinfection and Washing Technology Co Ltd527046468manufacture(58686-013)
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