Label: AUSTRALIAN GOLD ALOE GEL WITH LIDOCAINE- lidocaine hydrochloride 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 May 12, 2020

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  • Active ingredients

    Lidocaine Hydrochloride(0.5 %)

  • Purpose

    External Analgesic

  • Indications

    For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

  • Warnings

    For external use only

    Avoid contact with eyes

    if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor

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

    Keep out of reach of children. if product is swallowed, get medical help or contact a poison control center right away.

    For external use only.

    Avoid contact with eyes.

    If conditions worsens, or is symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

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

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Adults and children 2 years of age and older:

        Apply to afftected area not more than 3 to 4 times daily.

    • Children under 2 years of age:

        consult a doctor.

  • Inactive Ingredients

    Allantoin, Aloe Barbadensis Leaf Juice, Blue 1, Caprylyl Glycol, Carbomer, Citrus Limon (Lemon) Peel Extract, Glycerin, Glyceryl Acrylate/Acrylic Acid Copolymer, Hexylene Glycol, Mentha Viridis (Spearmint) Leaf Oil, Panthenol, PEG-60 Lanolin, Phenoxyethanol, Pollen Extract, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Symphytum Officinale (Comfrey) Leaf Extract, Tilia Cordata Flower Extract, Tocopheryl Acetate, Water

  • Questions or Comments?

    Call toll free 1-855-LIV-GOLD (546-4653)

  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD  ALOE GEL WITH LIDOCAINE
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0327
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5.05 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SCOTCH SPEARMINT OIL (UNII: I5T0098W81)  
    PEG-60 LANOLIN (UNII: K2OI1D27ET)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    BEE POLLEN (UNII: 3729L8MA2C)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    ALPHA-TOCOPHERYLQUINONE (UNII: ZO763K43XR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0327-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/16/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/16/2015
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0327) , pack(58443-0327) , manufacture(58443-0327) , analysis(58443-0327)
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