Label: FRUIT OF THE EARTH ALOE VERA COOL BLUE- lidocaine hydrochloride gel

  • NDC Code(s): 62217-200-20
  • Packager: Fruit of the Earth, Inc.
  • 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 December 18, 2017

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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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