FRUIT OF THE EARTH COOL BLUE ALOE VERA COOLING (MENTHOL, ALLANTOIN) GEL [FRUIT OF THE EARTH, INC.]

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FRUIT OF THE EARTH COOL BLUE ALOE VERA COOLING (MENTHOL, ALLANTOIN) GEL [FRUIT OF THE EARTH, INC.]
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NDC 62217-007-33, 62217-007-34
Set ID 4bba3a8d-323b-5f45-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Fruit of the Earth, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active Ingredients

    Menthol 0.5%, Allantoin 0.2%

  • Purpose

    External Analgesic

  • Uses

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

  • Warnings

    • EXTERNAL USE ONLY
  • Do not use

    in large quantities, particularly over raw surfaces or blistered areas

  • When using this product

    • Keep out of eyes and eyelids. If contact with eyes occurs, rinse with water to remove.
  • Stop use and ask a doctor if

    • Irritation or rash develops
    • Condition worsens, or if symptoms persist for 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
    • Children under 2 years of age, ask a doctor.
  • Inactive Ingredients:

    Aloe Vera Gel, Isoceteth-20, Triethanolamine, Carbomer, Benzophenone 4, Tetrasodium EDTA, Propylene Glycol, Methylparaben, Propylparaben, Diazolidinyl Urea, Blue #1.

  • PRINCIPAL DISPLAY PANEL

    1310ME1MF1

    13112ME1MF1

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH  COOL BLUE ALOE VERA COOLING
    menthol, allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg  in 1 g
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-007-33113 g in 1 BOTTLE; Type 0: Not a Combination Product09/30/2013
    2NDC:62217-007-34340 g in 1 BOTTLE; Type 0: Not a Combination Product09/30/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/30/2013
    Labeler - Fruit of the Earth, Inc. (079559467)
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