Label: FIRST AID BURN- benzalkonium chloride, lidocaine hydrochloride cream

  • NDC Code(s): 59898-902-01, 59898-902-02, 59898-902-03, 59898-902-36
  • 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 November 30, 2017

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

View All Sections
  • Active ingredients

    Benzalkonium chloride 0.13%

    Lidocaine HCl  0.5%


  • Purpose

    First Aid antiseptic

    External analgesic


  • Uses

    first aid to help prevent infection and for the temporary relief of pain and itching associated with

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Do not use

    • in the eyes or apply over large areas of the body
    • longer than 1 week unless directed by a doctor
    • in large quantities, particularly over raw surfaces or blistered areas

    Ask a doctor before use if you have

    deep or puncture wounds, animal bites, or serious burns

    When using this product

    avoid contact with eyes

    Stop use and ask a doctor if

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

    Keep out of the 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:
    •     clean the affected area
    •     apply a small amount of this product on the area 1 to 3 times daily
    •     may be covered with a sterile bandage
    •     children under 2 years of age: consult a doctor
  • Other information

    • store at room temperature (do not freeze)
    • tamper evident sealed packets
    • do not use if packet is opened or torn
    • you may report a serious reaction to this product to 800-275-3433
  • Inactive ingredients

    water, mineral oil, stearic acid, glyceryl stearate se, glycerin, Peg-100, cetyl alcohol, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, aloe barbadensis leaf juice, triethanolamine, disodium EDTA

  • Questions?

    800-275-3433   info@waterjel.com   www.waterjel.com

  • Principal Display Panel

    First Aid/Burn Cream

  • INGREDIENTS AND APPEARANCE
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-902
    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
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-902-011728 in 1 CARTON04/20/2010
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:59898-902-02144 in 1 BOX, UNIT-DOSE04/20/2010
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:59898-902-0325 in 1 BOX, UNIT-DOSE04/20/2010
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:59898-902-360.9 g in 1 PACKET; Type 0: Not a Combination Product04/20/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/20/2010
    Labeler - Water-Jel Technologies (155522589)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(59898-902)
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!