Label: BURN RELIEF CONTINUOUS- lidocaine spray

  • 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 April 8, 2020

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

View All Sections
  • ACTIVE INGREDIENT

    Lidocaine USP 0.50%

  • PURPOSE

    Purpose ..................External analgesic

  • INDICATIONS & USAGE

    Uses Temporary Relief of pain and itching due to: sunburn, minor burns, minor cuts scrapes, insect bites, minor skin irritations

  • WARNINGS

    Warnings

    For external use only

    DO not use in large quantities, particularly over raw surfaces or blistered area

  • WHEN USING

    When using this product, avoid contact with eyes, use only as directed, do not puncture or incinerate, content under pressure, do not store at temperature above 120 F.

  • STOP USE

    Stop use and ask a doctor if, condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children, In case of accidental ingestion seek professional assistance or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Direction, Shake well, adults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Wash hands with soap. Children under 2 years of age: consult a doctor. to apply to face, spray into palm of hand and gently apply.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Barbadensis Leaf Extract

    Carbomer

    Diazolidinyl Urea

    Disodium Cocoamphodipropionate

    Disodium EDTA

    Glycerin

    Methylparaben

    Propylene Glycol

    Propylparaben

    SD Alcohol 40

    Simethicone

    Tocopheryl Acetate

    Triethanolamine

  • PRINCIPAL DISPLAY PANEL

    Signature Care Burn Relief Continuous Spray

  • INGREDIENTS AND APPEARANCE
    BURN RELIEF CONTINUOUS 
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-144
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-144-01128 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/09/2020
    Labeler - Safeway (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC.081030372manufacture(21130-144)
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!