Label: GIGI ANESTHETIC NUMBING- lidocaine aerosol

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 10, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT - LIDOCAINE 4%
    PURPOSE - NUMBING
  • PURPOSE

    Uses: Lidocaine is a topical anesthetic that penetrates the surface of the skin, numbing the area to be epilated within minutes.
  • WARNINGS AND PRECAUTIONS

    Warnings: For external use only. Avoid spraying in eyes. Do not spray directly on face. Discontinue use if irritation occurs. If accidentally ingested, seek medical assistance immediately. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.
    FLAMMABLE. KEEP AWAY FROM HEAT AND FLAME. KEEP OUT OF REACH OF CHILDREN.
  • DOSAGE & ADMINISTRATION

    Directions - Before waxing large areas (legs, backs, arms, underarms and bikini areas) spray directly onto the skin. Do not spray near eyes or mouth. For waxing any part of the face, spray onto cloth, cotton ball or swab. Wait approximately 2-3 minutes for skin to numb, then proceed with waxing service. After waxing, spray or apply with cloth, cotton ball or swab for added comfort.
  • PRINCIPAL DISPLAY PANEL

    GiGi Anesthetic Numbing Spray
    for sensitive skin
    Temporarily numbs the skin taking the sting out of waxing while soothing the skin.
    Numbing Spray Label

    Numbing Spray Can



  • INGREDIENTS AND APPEARANCE
    GIGI ANESTHETIC NUMBING 
    lidocaine aerosol
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57367-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOBUTANE (UNII: BXR49TP611)  
    THYMOL (UNII: 3J50XA376E)  
    EUGENOL (UNII: 3T8H1794QW)  
    ALCOHOL (UNII: 3K9958V90M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    OLETH-5 (UNII: 1GH33785AY)  
    ISODODECANE (UNII: A8289P68Y2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57367-001-0142 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34810/27/1997
    Labeler - 220 LABORATORIES INC (783247950)
    Registrant - 220 LABORATORIES INC (783247950)
    Establishment
    NameAddressID/FEIBusiness Operations
    220 LABORATORIES INC783247950manufacture
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