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

  • NDC Code(s): 58686-013-01, 58686-013-02
  • Packager: Chengdu Shunfa Disinfection and Washing Technology Co Ltd
  • 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 June 5, 2013

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  • ACTIVE INGREDIENTS

    Didecyldimethyl Ammonium 0.3%

    Triclosan                              0.3%

    Borneol                               0.4%

    Benzalkonium Bromide       0.3%

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  • PURPOSES

    Antibacterial

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  • KEEP OUT OF REACH OF CHILDREN.

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

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  • DO NOT USE

    if you are allergic to any of the ingredients.

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  • WHEN USING THIS DEVICE

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

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  • STOP USE AND ASK A DOCTOR IF

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

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  • USES

    Uses spray to reduce bacteria on the skin.

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  • WARNINGS

    For external use only.

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  • 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.

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  • INACTIVE INGREDIENTS

    Polyethylene Glycol, Menthol, Water

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  • INGREDIENTS AND APPEARANCE
    SHUNFA ANTI-BACTERIA SPRA 
    didecyldimethyl ammonium,triclosan, borneol, benzalkonium bromide spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58686-013
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIDECYLDIMETHYLAMMONIUM (UNII: Z7F472XQPA) (DIDECYLDIMETHYLAMMONIUM - UNII:Z7F472XQPA) DIDECYLDIMETHYLAMMONIUM 3 mg  in 1000 mg
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 3 mg  in 1000 mg
    BENZALKONIUM BROMIDE (UNII: 151T1GQ42D) (BENZALKONIUM BROMIDE - UNII:151T1GQ42D) BENZALKONIUM BROMIDE 3 mg  in 1000 mg
    BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X) BORNEOL 4 mg  in 1000 mg
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58686-013-01 30 mg in 1 BOTTLE, SPRAY
    2 NDC:58686-013-02 5 mg in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 10/30/2005
    Labeler - Chengdu Shunfa Disinfection and Washing Technology Co Ltd (527046468)
    Registrant - Chengdu Shunfa Disinfection and Washing Technology Co Ltd (527046468)
    Establishment
    Name Address ID/FEI Business Operations
    Chengdu Shunfa Disinfection and Washing Technology Co Ltd 527046468 manufacture(58686-013)
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