Label: 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 February 3, 2020

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

View All Sections
  • Active Ingredients

    Active Ingredient

    Lidocaine HCL 0.5%

    Benzalkonium Chloride 0.13%

  • Purpose

    First aid antiseptic, external analgesic

    Temporary relief of pain associated with minor burns

  • Uses

    First aid to help prevent infection and for the temporary relief of pain and itching associated with minor cuts, scrapes and burns.

  • WARNINGS

    EXTERNAL USE ONLY

  • KEEP OUT OF REACH OF CHILDREN

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

  • DO NOT USE

    DO NOT USE:

    • in eyes
    • in large quantities
    • over raw blistered areas or on deep punctured wounds, animal bites or serious burns
    • for more than one week

  • Directions

    • Clean affected area
    • apply small amount not more than 3 times daily
    • maybe covered with a sterile bondage
  • Inactive ingredients

    inactive ingredient

  • Other Information

    Other Information

    Store at room temperature

  • Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    FIRST AID BURN CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70897-001
    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
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYL PARAOXON (UNII: UE1A2XL95H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIISOPROPYL PARAOXON (UNII: R90A2849YV)  
    ALLANTOIN (UNII: 344S277G0Z)  
    TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)  
    STEARIC ACID D7 (UNII: T3B081197X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70897-001-010.9 g in 1 BAG; Type 0: Not a Combination Product08/11/2016
    2NDC:70897-001-0242.5 g in 1 BAG; Type 0: Not a Combination Product08/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/09/2016
    Labeler - Davemed Healthcare Co., Ltd (529128716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Davemed Healthcare Co., Ltd529128716manufacture(70897-001)
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!