Label: BURN CREAM- benzalkonium chloride, lidocaine hci cream

  • NDC Code(s): 69396-136-10, 69396-136-25
  • Packager: Trifecta Pharmaceuticals USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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

View All Sections
  • Active Ingredient

    Lidocaine HCL 0.5%

  • Purpose

    Topical Analgesic

  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.13%

  • Purpose

    First Aid Antiseptic

  • Uses

    Temporary Relief of pain associated with minor cuts, scrapes and burns.

    Helps protect against harmful bacteria.

  • Warnings

    For external Use Only

    Do not use

    • in eyes
    • in large quantities
    • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
    • for more than one week unless directed by a doctor
  • Directions

    • Clean the affected area
    • Apply a small amount not more than 3 times daily
    • May be covered with a sterile bandage
  • Inactive Ingredients

    Aloe barbadensis leaf juice, Cetyl alcohol, Diazolidinyl urea, Edetate disodium, glycerin, methylparaben, Mineral oil, Mono and di glycerides, PEG-100 stearate, propylene glycol, propylparaben, stearic acid, triethanolamine, water

  • Questions

    Call: 1-888-296-9067

  • Storage Information

    • Store in cool dry area 15° to 25°C (59° to 77°F).
    • tamper evident sealed packets
    • do not use any opened or torn packets
  • Keep out of reach of children

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

  • Other Information

    Distributed By:

    Trifecta Pharmaceuticals USA®

    101 NE Third Ave. Ste 1500

    Ft. Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

  • Package Label

    R519539 GLOBE FIRST AID BURN CREAM 0.9G 10CT 092623 CDER

  • Package Label

    R519541 GLOBE FIRST AID BURN CREAM 0.9G 25CT 092623 CDER

  • INGREDIENTS AND APPEARANCE
    BURN CREAM 
    benzalkonium chloride, lidocaine hci cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-136
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.005 g  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-136-1010 in 1 CARTON10/23/2023
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69396-136-2525 in 1 CARTON10/23/2023
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00310/23/2023
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!