Label: GOODSENSE BURN RELIEF GEL- lidocaine hcl 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 June 28, 2019

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  • Active Ingredients

    Lidocaine 0.5%

  • Purpose

    Topical Analgesic

  • Uses

    • tempory relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, minor skin irritations, and insect bites.

    Dosage & Administration

    For temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, and poison oak.

  • Warnings

    For external use only

  • Do not use

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

  • When using this product

    When using this product avoid contact with the eyes.

  • Stop use and ask a doctor

    if condition worsens or if symptoms persist for more than 7 days or 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, Blue 5, Carbomer. Disodium, EDTA Glycerin, Menthol, Phenoxyethanol, Polysorbate 20, Propanediol, SD Alcohol (1.85% w/w). Sodium Hydroxide, Water, Yellow 5

  • Questions or Comments?

    www.valuelabels.com

  • Principal Display Panel

    GOODSENSE

    BURN RELIEF

    GEL

    with

    Lidocaine HCl

    • Soothes & Relieves
    • Restores Moisture
    • Topical Analgesic Gel

    with ALOE

    Compare to active ingredients of

    Solarcaine

    100% satisfaction guaranteed

    NET WT 8 OZ (226 g)

    PKLA-41212-GSF1

    GoodSense Burn Relief Gel Front Label.jpg

    GoodSense Burn Relief Gel Back Label.jpg

  • INGREDIENTS AND APPEARANCE
    GOODSENSE BURN RELIEF GEL 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-618
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BASIC YELLOW 5 (UNII: 07BP340B4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70281-618-26226 g in 1 BOTTLE; Type 0: Not a Combination Product01/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/04/2019
    Labeler - Solskyn Personal Care LLC (080010329)
    Establishment
    NameAddressID/FEIBusiness Operations
    KIK Piedmont LLC078482780manufacture(70281-618)
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