Label: FRUIT OF THE EARTH SUN TOWN CITY ALOE VERA AFTER SUN WITH LIDOCAINE HCL- lidocaine gel

  • NDC Code(s): 62217-070-68, 62217-070-80
  • 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 July 21, 2021

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  • Active Ingredients

    Lidocaine 0.8% (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

    in large quantities, particularly over raw surfaces or blistered areas

  • 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.
  • Other information:

    May stain some fabrics.

  • Inactive ingredients:

    water, aloe barbadensis leaf juice, alcohol denat., propylene glycol, laureth-23, glycerin, polysorbate 20, allantoin, carbomer, triethanolamine, menthyl lactate, disodium EDTA, menthol, aleurites moluccarnus seed extract, carica papaya (papaya) fruit extract, colocasia antiquorum root extract, mangifera indica (mango) fruit extract, passiflora incarnata flower extract, plumeria acutifolia flower extract, psidium guajava fruit extract, tocopheryl acetate, tocopherol, phenoxyethanol, benzyl alcohol, fragrance, Blue 1, Yellow 5.

  • PRINCIPAL DISPLAY PANEL

    83645EF1

    83648EF1

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH SUN TOWN CITY ALOE VERA AFTER SUN WITH LIDOCAINE HCL 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE8 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LAURETH-23 (UNII: N72LMW566G)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHOL (UNII: L7T10EIP3A)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)  
    MANGO (UNII: I629I3NR86)  
    GUAVA (UNII: 74O70D6VG0)  
    PAPAYA (UNII: KU94FIY6JB)  
    PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z)  
    COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)  
    ALEURITES MOLUCCANA SEED (UNII: J87WJ3E7VW)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-070-80227 g in 1 BOTTLE; Type 0: Not a Combination Product12/09/2019
    2NDC:62217-070-68453 g in 1 BOTTLE; Type 0: Not a Combination Product12/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/09/2019
    Labeler - Fruit of the Earth, Inc. (079559467)
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