Label: BROMPTON AND LANGLEY LAVENDER VANILLA HAND SANITIZER LAVENDER VANILLA- alcohol denat gel

  • 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 13, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient

    Alcohol 62%

    Purpose: Antiseptic

  • PURPOSE

    Use

    To decrease bacteria on the skin that could cause disease.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNINGS

    Warnings

    • Keep away from flame or fire
    • for external use only-hands.
    • keep out of eyes.
    • stop use and ask a Doctor if irritation or redness persists for more than 72 hours
    • do not inhale or ingest. if swallowed, get medical help or contact a poison control center right away.
  • DOSAGE & ADMINISTRATION

    Directions

    • spray a thumb size amount into hands.
    • rub hands together gently making sure to cover all areas in between fingers
    • let hands air dry
  • INACTIVE INGREDIENT

    Inactive Ingredients

    water (aqua/eau), glycerin, propylen glycol, Isopropyl alcohol, phenoxythenol, acrylates,

    lauryl glycol ether, carbomer, Vitamin E, fragrance (parfum).

  • INDICATIONS & USAGE

    Brompton and Langley
    Lavender Vanilla Scentend Hand Sanitizer
    15mL

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    BROMPTON AND LANGLEY LAVENDER VANILLA HAND SANITIZER  LAVENDER VANILLA
    alcohol denat gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70805-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.26 g  in 26 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHOXY PEG-40 (UNII: 6AXS45P1QU)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorVANILLA (Lavender Vanilla) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70805-006-0115 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/13/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/03/2016
    Labeler - Cita International Limited (665926739)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cita International Limited665926739manufacture(70805-006)
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