Label: HUNTER BEACH 4%- lidocaine gel

  • 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 April 11, 2022

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  • Drug Facts

  • Active ingredient

    Lidocaine 4%

  • Purpose

    Topical Anesthetic

  • Uses

    • Temporary relief of pain and itching
    • Helps relieve and soothes pain from sunburn, minor burns, skin irritations, scrapes, insect bites

  • Warnings 

    For external use only.

    Do not use in large quantities, particularly over raw surfaces or areas with blisters.

    When using this product avoid contact with eyes. Use only as directed. Intentional misuse by deliberate concentrating and inhaling the contents can be harmful or fatal.
    Stop use and consult a doctor if condition worsens, or symptoms last more than 7 days. Symptoms clear up and occur again within a few days.

    Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away

  • Directions 

    • Adults and children 2 years or older: apply to affected area not more than 3-4 times daily
    • Children under 2 years of age: do not use, ask a doctor.

  • Inactive ingredients 

    Aloe Barbadensis Leaf Juice, Glycerin, Triethanolamine, Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, DMDM Hydantoin, Fragrance, FD&C Blue #1.

  • SPL UNCLASSIFIED SECTION

    NEW!

    Lidocaine Gel with Aloe Vera

    Instant Maximum Relief For Severe Sunburns

    Distributed by Hunters Beach Life,
    1707 State Ave., Holly Hill, FL 32117
    www.HUNTERBEACH.com
    Made in the U.S.A.

  • Packaging

    Gel

  • INGREDIENTS AND APPEARANCE
    HUNTER BEACH 4% 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82517-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82517-002-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2022
    Labeler - HUNTERS BEACH LIFE (034619724)
    Establishment
    NameAddressID/FEIBusiness Operations
    Absolutely Natural166425202manufacture(82517-002)
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