FRUIT OF THE EARTH COOL BLUE ALOE MIST CONTINUOUS (LIDOCAINE HYDROCHLORIDE) SPRAY [FRUIT OF THE EARTH, INC.]

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  • FRUIT OF THE EARTH COOL BLUE ALOE MIST CONTINUOUS (LIDOCAINE HYDROCHLORIDE) SPRAY [FRUIT OF THE EARTH, INC.]

FRUIT OF THE EARTH COOL BLUE ALOE MIST CONTINUOUS (LIDOCAINE HYDROCHLORIDE) SPRAY [FRUIT OF THE EARTH, INC.]
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NDC 62217-201-20
Set ID aa39c75e-5efb-435b-95ab-a41cfc36e4f2
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%)

  • Purpose

    External Analgesic

  • Uses

    For the temporary relief of sunburn, minor burns, scrapes, insect bites, minor rashes, minor skin irritations and windburned skin.

  • Warnings

    • EXTERNAL USE ONLY
    • Do not use near heat, flame or while smoking. Avoid long term storage above 104°F (40°C).
    • Do not spray directly in eyes or face.
    • May stain some fabrics.
  • DO NOT USE

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

    • Do not use on puncture wounds
  • When using this product

    • Keep out of eyes and eyelids. If contact with eyes occurs, rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
  • Stop use and ask a doctor if

    • Condition worsens, or if symptoms persist more than 7 days or clear up and occur again within a few days
  • 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
    • Spray on hands to apply to face.
    • Use in a well-ventilated area.
    • Children under 2 years of age, ask a doctor.
  • Inactive Ingredients

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

  • Fruit of the Earth Cool Blue Aloe Mist Continuous Spray 177 mL NDC: 62217-201-20

    Label

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH COOL BLUE ALOE MIST CONTINUOUS 
    lidocaine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-201-20177 mL in 1 CANISTER; Type 0: Not a Combination Product09/12/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/12/2014
    Labeler - Fruit Of The Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-201)
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