Label: BURN RELIEF GEL- lidocaine hydrochloride 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 February 19, 2021

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  • Active Ingredients

    Active ingredients

    Lidocaine Hydrochloride 0.5%

  • Purpose

    Purpose

    Topical Anesthetic

  • Uses

    Uses

    Temporary relief of pain and itching. Helps to relieve and soothe pain from sunburn, minor burns, skin irritations, scrapes, insect bites.

  • Warnings

    Warnings

    For external use only

  • Other Warnings

    other warning

    Avoid Contact with eyes.

    Stop use and ask a doctor if:

    condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop use

    Pregnancy/breast-feeding warning

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

    Do not use

    in large quantity, particularly over raw surfaces or areas with blisters. do not use

  • Keep out of reach of children.

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

  • Directions

    Adults and children 2 years or older: apply generously to the burned area. Repeat application as often as necessary (no more than four times daily) to further extinguish pain. Children under 2 years of age: do not use, ask a doctor Directions

  • Inactive ingredients

    acrylates/C1030 alkyl acrylate crosspolymer, alcohol denatured, algae extract, aloe barbadensis leaf juice, butylene glycol, ehtylhexylglycerin, FD&C Blue No. 1, fragrance, glycerin, menthyl lactate, PEG-40 hydrogenated castor oil, phenoxyethanol, polysorbate 20, PPG-26-butheth-26, simmondsia chinensis (jojoba) extract, triethanolamine, water. Inactive ingredients

  • Questions or comments?

    Call 855-sea-n-ski (855-732-6754) or visit www.seaNski.com questions or comments

  • PRINCIPAL DISPLAY PANEL

    Front Label

  • INGREDIENTS AND APPEARANCE
    BURN RELIEF GEL 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73440-2161
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2.4123 g  in 482.46 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 436.1 g  in 482.46 g
    Product Characteristics
    Colorblue (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73440-2161-1482.46 g in 1 BOTTLE; Type 0: Not a Combination Product02/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/08/2021
    Labeler - Cross Brands Contract Filling (117871824)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cross Brands Contract Filling117871824label(73440-2161) , manufacture(73440-2161) , pack(73440-2161)
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