Label: ALOCANE BOTANICALS- lidocaine hydrochloride spray

  • NDC Code(s): 68229-405-01, 68229-405-02
  • Packager: Quest Products, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Lidocaine HCL 4%

  • Purpose

    Topical Pain Relief

  • Uses

    For the temporary relief of pain and itching associated with:

    • Sunburn
    • Minor Skin Irritation
    • Minor Burns
    • Minor Cuts & Scrapes
    • Insect Bites
  • Warnings

    For external use only. Avoid contact with eyes.

    Do not use: ​

    • in large quantities, or over large areas of the body
    • Over raw surfaces or blistered areas
    • If you have an allergy to any of the ingredients

    Ask a doctor before use if you have a severe burn or deep cut, broken or compromised skin

    Stop use and ask doctor:

    • if condition worsens
    • 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, get medical help or contact a Poison Control Center right away.

    If pregnant or breast-feeding, ask a health care professional before use.

  • Directions:

    Adults and Children 2 years of age or older:

    Shake well. Apply top affected area not more than 3-4 times daily. To apply to face, spray on palm and carefully apply.

    Children under 2 years of age, ask a doctor before use.

  • Other Information

    Store at 15-30°C (59-86°F)

  • Inactive Ingredients

    Water, Phenoxyethanol, Aloe Vera Leaf Juice, Lactobacilus Ferment, Echinacea Purpurea Root Extract, Calendula Officinalis Flower Extract, Sodium Hyaluronate, D-Panthenol, Glycerin, Hydroxyethyl Cellulose, Mannitol, Sodium Hydroxide

  • PRINCIPAL DISPLAY PANEL -- Alocane Botanicals 4oz Spray Bottle

    PDP4oz

  • INGREDIENTS AND APPEARANCE
    ALOCANE BOTANICALS 
    lidocaine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68229-405
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68229-405-01118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/11/2023
    2NDC:68229-405-02104 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/11/2023
    Labeler - Quest Products, LLC. (075402441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fill Tech USA926433855manufacture(68229-405)
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