SUNBURNT PLUS PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) GEL [DENISON PHARMACEUTICALS, LLC.]

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  • SUNBURNT PLUS PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) GEL [DENISON PHARMACEUTICALS, LLC.]

SUNBURNT PLUS PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) GEL [DENISON PHARMACEUTICALS, LLC.]
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NDC 0295-1110-21
Set ID 021250a7-31c3-4877-bc14-1565e455c234
Category HUMAN OTC DRUG LABEL
Packager Denison Pharmaceuticals, LLC.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Lidocaine hydrochloride 1.0%

  • Purpose

    External analgesic

  • Uses

    Temporarily relieves pain and itching due to:

    • sunburn
    • minor burns
    • insect bites
    • minor skin irritations
    • minor cuts
    • scrapes
  • Warnings

    For external use only

    Do not use

    • in large quantities, particularly over raw surfaces or blistered areas
    • if you have an allergy or hypersensitivity to any ingredients

    Ask a doctor before use if

    • you have severe sunburn
    • you have a rash or broken or compromised skin

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or 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

    • clean skin and apply to affected area
    • adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
    • children under 2 years of age: ask a doctor
  • Other information

    • store at 15-30ºC (59-86ºF)
    • do not use if seal under cap is open or missing
  • Inactive ingredients

    water, ethyl alcohol, echinacea angustifolia extract, calendula officinalis extract, cantharis vesicatoria extract, gelidiella acerosa extract, hypnea musciformis extract, cucumis sativus (cucumber) seed extract, aloe barbadensis leaf juice, panthenol, sodium hyaluronate, carbomer, sodium hydroxide, phenoxyethanol, ethylhexylglycerin

  • Questions or Comments?

    1-888-565-2876 Monday through Friday, 9am-5pm EST

  • SPL UNCLASSIFIED SECTION

    Dist. by: Welmedix Consumer Healthcare
    Princeton, New Jersey 08540

  • PRINCIPAL DISPLAY PANEL - 142 g Tube Carton

    NEW!

    SUN
    BURNT®
    PLUS
    PAIN RELIEF GEL
    with LIDOCAINE HCL 1%

    FAST RELIEF FOR
    PAIN & ITCH

    ULTRA
    HYDRATING

    NOURISHING
    BOTANICALS

    NON-STICKY
    FORMULA

    Net Wt 5 oz (142 g)

    PRINCIPAL DISPLAY PANEL - 142 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SUNBURNT PLUS PAIN RELIEF 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)  
    LYTTA VESICATORIA (UNII: 3Q034RO3BT)  
    GELIDIELLA ACEROSA (UNII: T91K54D6M1)  
    HYPNEA MUSCIFORMIS (UNII: W6FF9R1FJV)  
    CUCUMBER SEED (UNII: BT3S9L53JK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Panthenol (UNII: WV9CM0O67Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Sodium hydroxide (UNII: 55X04QC32I)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-1110-211 in 1 CARTON03/15/2018
    1142 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34803/15/2018
    Labeler - Denison Pharmaceuticals, LLC. (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC.001207208manufacture(0295-1110)
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