Label: DR. ROTHMANS DERMASHIELD- instant and long lasting sanitizer and moisturizer spray

  • 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 December 4, 2014

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  • ACTIVE INGREDIENT

    Active Ingredients

    • Ethyl Alcohol - 62%
    • Benzalkonium Chloride - 0.10%
  • KEEP OUT OF REACH OF CHILDREN

    Warning

    • Keep out of reach of children.
  • PURPOSE

    Purpose

    • Antiseptic
    • Antibacterial
  • WHEN USING

    Directions

    • Apply by spraying and gently spreading onto skin.
  • WARNINGS

    Warning  

    • For external use only.
    • Flammable keep away from fire or flame
    • Do not use in eyes. In case of contact, rinse eyes thoroughly with water.
  • ASK DOCTOR

    Warning

    • Stop use and ask doctor if irritation and redness persist for more than 72 hours.
  • INDICATIONS & USAGE

    Sanitizer and moisturizer

  • DOSAGE & ADMINISTRATION

    Apply by spraying and gently spreading onto skin

  • INACTIVE INGREDIENT

    Blended Silicone Polyethers

  • PRINCIPAL DISPLAY PANEL

    Dr Rothman's Dermashield

    Image of bottle label

  • INGREDIENTS AND APPEARANCE
    DR. ROTHMANS DERMASHIELD 
    instant and long lasting sanitizer and moisturizer spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:89153-796
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol37.2 g  in 60 g
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.06 g  in 60 g
    Inactive Ingredients
    Ingredient NameStrength
    Dimethicone (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:89153-796-0460 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2015
    Labeler - High Desert Pharmaceutics, Inc. (830018433)
    Registrant - All Points Manufacturing, LLC (079267697)
    Establishment
    NameAddressID/FEIBusiness Operations
    All Points Manufacturing, LLC079267697manufacture(89153-796)
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