Label: SAVANNAH ANTISEPTIC- 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 June 30, 2016

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  • Drug FactsActive Ingredients

    Benzalkonium Chloride 0.133%

  • Purpose

    First Aid Antiseptic

  • Use

    Antiseptic cleansing of face, hands and body without soap and water. Air dries in seconds.

  • Warnings

    For external use only. Do not use around eyes.

  • Stop use if

    if irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

  • Keep out of reach of children

    Caution Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Tear open packet, unfold and use as a washcloth.

  • Inactive Ingredients

    Kathon CG, Water

  • Savannah product label

    Savannah

    NDC 59647-749-02

    Antiseptic Towelette

    Contains Benzalkoniun Chloride

    For External use Only

    1 Towelette

    R & R Enterprises

    (800) 955-2259

    Made in USA

    EXP: 07/18

    LOT 20016 ABC

    Med-Nap Savannah label

  • INGREDIENTS AND APPEARANCE
    SAVANNAH  ANTISEPTIC
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59647-749
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1.4 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MAGNESIUM CHLORIDE ANHYDROUS (UNII: 59XN63C8VM)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59647-749-021.4 g in 1 PACKET; Type 0: Not a Combination Product07/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/01/2016
    Labeler - Med-Nap LLC (079086400)
    Registrant - Med-Nap LLC (079086400)
    Establishment
    NameAddressID/FEIBusiness Operations
    Med-Nap LLC079086400manufacture(59647-749)
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