Label: ALOE ICE SUNBURN RELIEF- lidocaine hydrochloride gel

  • NDC Code(s): 61477-101-11, 61477-101-14
  • Packager: Aloe Care International, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 13, 2024

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  • ACTIVE INGREDIENTS

    LIDOCAINE HYDROCHLORIDE  2%

  • PURPOSE

    PAIN RELIEF

  • USES

    TEMPORARY PAIN ASSOCIATED WITH MINOR BURNS

  • DIRECTIONS

    APPLY GENEROUSLY TO AFFECTED AREA.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    FOR EXTERNAL USE ONLY, NOT TO BE SWALLOWED. AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

  • STOP USE

    STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR PERSISTS FOR MORE THAN 7 DAYS OR CLEARS UP AND RETURNS.

  • INACTIVE INGREDIENTS

    Aloe Barbadensis Leaf Juice, Blue 1 (CI 42090), Carbomer, Disodium EDTA, Iodopropynyl Butylcarbamate, Methylisothiazolinone, Polysorbate 20, Propylene Glycol, Triethanolamine, Water

  • QUESTIONS OR COMMENTS?

    1-800-950-2563  *  WWW.ALOEUP.COM

  • PRINCIPAL DISPLAY PANEL

    Aloe Ice 1oz Finals 2017

  • INGREDIENTS AND APPEARANCE
    ALOE ICE SUNBURN RELIEF 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61477-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOMER 934 (UNII: Z135WT9208)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61477-101-14120 mL in 1 TUBE; Type 0: Not a Combination Product02/24/2014
    2NDC:61477-101-1160 mL in 1 TUBE; Type 0: Not a Combination Product02/24/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/24/2014
    Labeler - Aloe Care International, LLC (938242187)
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