Label: BURN JEL PLUS- gel for burns gel

  • NDC Code(s): 59898-202-10, 59898-202-11, 59898-202-12, 59898-202-13
  • Packager: Water-Jel Technologies
  • 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 1, 2017

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

View All Sections
  • Active ingredient

    Lidocaine HCl 2.5%

  • Purpose

    External analgesic

  • Uses

    for the temporary relief of pain associated with minor burns

  • Warnings

    For external use only

    Do not use

    in large quantities, particularly over raw surfaces or blistered areas

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • conditions worsens
    • symptoms persist for more than 7 days
    • condition clears up and occurs again within a few days

    Keep out of reach of children.

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

  • Directions

    • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a doctor
  • Inactive ingredients

    carbomer 940, carbomer 1342, diazolidinyl urea, edetate disodium, glycerin, methylparaben, octoxynol 9, propylene glycol, propylparaben, purified water, tea tree oil, trolamine, vitamin E acetate

  • Questions ?

    1-800-275-3433 www.waterjel.com

  • Principal Display Panel

    Burn Jel Plus

  • INGREDIENTS AND APPEARANCE
    BURN JEL PLUS 
    gel for burns gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    CARBOMER COPOLYMER TYPE B (UNII: 1G56KV7BUJ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-202-101 in 1 CARTON04/10/2010
    159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:59898-202-1124 in 1 CARTON04/10/2010
    259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:59898-202-121 in 1 CARTON04/10/2010
    3118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:59898-202-1324 in 1 CARTON04/10/2010
    4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/10/2010
    Labeler - Water-Jel Technologies (155522589)
    Registrant - Water-Jel Technologies (155522589)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(59898-202)
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!