Label: TOP SAFETY FIRST AID BURN CREAM- lidocaine cream

  • 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 March 12, 2019

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Active Ingredient                                       Purpose

    Lidocaine HCL 0.5%                                   Topical Analgesic

    Benzalkonium Chloride 0.13%                    Topical Antiseptic

  • Purpose

    Temporary relief of pain and itching.

  • Uses

    For temporary relief of pain and itching associated with:

    • Sunburn
    • Minor burns,
    • Insect bites,
    • Minor skin irritation,
    • Cuts and 
    • Scrapes
  • Warnings

    FOR EXTERNAL USE ONLY

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Stop Use

    Stop Use and ask a doctor:

    • If condition worsens or,
    • if symptoms persist for more than 7 days or clear up and occur again in a few days.
    • If pregnant or breast feeding, ask a health professional before use.

  • Do Not Use

    Do Not Use:

    • In the eyes
    • Over large areas of the body or on deep puncture wounds, animal bites or serious burns.
    • In large quantities, particularly over raw surfaces or blistered areas.
  • Directions

    Adults and children 2 years and over:

    • clean the affected area
    • apply a small amount of this product on the area 3 or 4 times daily.
    • may be covered with a sterile bandage

    Children under 2 years

    • consult a doctor
  • Inactive ingredients

    Buttylated hydroxy toluene, Cetomacrogol, Cetostearyl alcohol, Dimethicone, Glycerine, Glyceryl monostearate, Isopropyl myristate, Methylcellulose, Purified water, Sodium EDTA, Sodium methylparaben, Sodium propylparaben

  • Other Information

    Other Information

    • store in a cool, dry area
    • 59o to 79o F (15o to 25o C)
    • Tamper evident sealed packets do not use any open or torn packets
  • Principal Display Panel

    Top Safety First Aid Burn Cream

    Top Safety.jpg

    TS First Aid Burn

  • INGREDIENTS AND APPEARANCE
    TOP SAFETY FIRST AID BURN CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51395-412
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETETH-20 (UNII: I835H2IHHX)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51395-412-012000 in 1 BOX02/16/2016
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/07/2016
    Labeler - Top Safety Products Company Inc (627999956)