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
  • 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 August 11, 2023

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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)  
    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)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    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 not finalpart34808/11/2023
    Labeler - Quest Products, LLC. (075402441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fill Tech USA926433855manufacture(68229-405)
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