FRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]

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FRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]
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NDC 62217-200-20
Set ID 1d65bc34-2bc2-4f52-a9b3-1cb08324eb79
Category HUMAN OTC DRUG LABEL
Packager Fruit of the Earth, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • Active Ingredients

    Lidocaine 1.0% (as Lidocaine HCl)

  • Purpose

    External Analgesic

  • Uses

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

  • Warnings

    • For External Use Only
  • DO NOT USE

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

  • WHEN USING

    When using this product avoid contact with eyes. If contact occurs, rinse with water to remove.

  • ASK DOCTOR

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

  • 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: Ask a doctor.
  • OTHER SAFETY INFORMATION

    Other Information: May stain some fabrics.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Isoceteth-20, Triethanolamine, Carbomer, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4, Blue 1.

  • PRINCIPAL DISPLAY PANEL

    Fruit of the Earth

    Aloe Vera

    Cool Blue Gel

    567 grams

    NDC: 62217-200-20

    Label Image

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH ALOE VERA COOL BLUE 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-200-20567 g in 1 BOTTLE; Type 0: Not a Combination Product09/10/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/10/2014
    Labeler - Fruit of the Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-200)
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