Label: FRUIT OF THE EARTH COOL BLUE ALOE VERA COOLING- menthol gel

  • NDC Code(s): 62217-080-33, 62217-080-34
  • Packager: Fruit of the Earth, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 July 30, 2021

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  • Active Ingredients

    Menthol 0.5%

  • 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

  • When using this product

    avoid contact with eyes. If contact occurs, rinse with water to remove.

  • 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

    • 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 barbadensis leaf juice, isoceteth-20, triethanolamine, carbomer, allantoin, benzophenone-4, tetrasodium EDTA, propylene glycol, methylparaben, propylparaben, diazolidinyl urea, blue 1, water.

  • PRINCIPAL DISPLAY PANEL

    13104ME2F2

    13112ME2F2

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH COOL BLUE ALOE VERA COOLING 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 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)  
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-080-33113 g in 1 BOTTLE; Type 0: Not a Combination Product09/30/2013
    2NDC:62217-080-34340 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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