DUANE READE BURN RELIEF PAIN RELIEVING GEL (LIDOCAINE HYDROCHLORIDE) GEL [DUANE READE INC.]

DUANE READE BURN RELIEF PAIN RELIEVING GEL (LIDOCAINE HYDROCHLORIDE) GEL [DUANE READE INC.]
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NDC 67732-406-16
Set ID f308f25c-9dd2-4445-9b50-f702511928dc
Category HUMAN OTC DRUG LABEL
Packager DUANE READE INC.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • Active Ingredient

    Lidocaine HCl 0.50%
  • Purpose

    Topical Anesthetic

  • Uses

    • temporary pain relief
    • helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect bites.
  • Warnings

    For external use only

    Do not use in large quantities, particularly over raw surfaces or blistered areas.

    When using this product

    • avoid contact with eyes.

    stop use and ask a doctor if

    • Conditions worsens or symptoms persists for more than 7 days.
    • Symptoms clear up and occur again within a few days.

    Keep out of reach of children.

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

  • Directions

    • adults and children 2 years of age and older.apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: do not use, ask a doctor.
  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Diazolidinyl urea, Disodium EDTA, Menthol, Yellow 5, Blue 1.

  • Principal Display Panel

    UNIQUELY NY DRTM SINCE 1960

    burn
    relief
    pain relieving gel
    with Lidocaine
    NET WT 8 OZ (227 g)
    ZDR008A0.jpg


  • INGREDIENTS AND APPEARANCE
    DUANE READE BURN RELIEF  PAIN RELIEVING GEL
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67732-406
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67732-406-16226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/13/2012
    Labeler - DUANE READE INC. (011988995)

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