Label: SCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC- lidocaine, benzalkonium chloride 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 December 16, 2022

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  • Drug Facts

  • Active Ingredients

    Lidocaine 2.00%
    Benzalkonium Chloride 0.13%

    Purpose

    Topical Analgesic/Anesthetic
    First Aid Antiseptic

  • Use

    For temporary relief of pain or discomfort, for first degree burns or superficial second degree burns and to help prevent infection in: minor burns, cuts, scrapes.

  • Warnings

    • For external use only

    Do not use 

    • for more than 1 week
    • in or near eyes
    • over an area larger than the palm of your hand

    Ask a doctor before use if 

    burn in severe

    Ask a doctor or pharmacist before use if

    • you have a history of heart disease or serious burns

    Stop use and ask a doctor if 

    increased redness or weeping or pain persist or clears up and occurs again within a few days

    Keep out of reach of children

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 2 years and over

    • clean the affected area
    • lightly apply to the affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • Children under 2 years, consult a doctor.
  • Inactive Ingredients

    allantoin, allium cepa (onion) bulb extract, aloe barbadensis leaf juice, benzyl alcohol, butylene glycol, calophyllum tacamahaca (tamanu) seed oil, camellia sinensis leaf extract, centella asiatica extract, citric acid, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylisothiazolinone, phenoxyethanol, phytonadione, polysorbate 60, propylene glycol, sodium polyacrylate, water (aqua).

  • Questions or Comments?

    • Call 1-800-595-6230 
  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    SCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC 
    lidocaine, benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-6174
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ONION (UNII: 492225Q21H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHYTONADIONE (UNII: A034SE7857)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61543-6174-51 in 1 BOX03/15/2019
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/14/2010
    Labeler - CCA Industries, Inc. (106771041)
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