Label: SELECT BRAND BURN RELIEF- lidocaine hcl gel

  • 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 19, 2012

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

View All Sections
  • Active ingredient

    Lidocaine HCL 0.50%
  • Purpose

    Topical Anesthetic
  • Uses

    • temporary relief of pain and itching
    • helps relieve and soothes pain from sunburn, minor burns,cuts,scrapes, skin irritations and insect bites
  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes.
    • do not use in large quantities, particularly over raw surfaces or blistered areas

    Stop use and ask a doctor if

    • condition worsens or if symptoms persist for more than 7 days.
    • if symptoms clear up and occur again within a few days.

    Keep out of reach of children.
    If swallowed get medical help or contact Poison Control Center immediately.

  • 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: ask a doctor
  • Inactive ingredients

    Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Aloe Barbadensis Leaf Juice, Menthol, Disodium EDTA, Diazolidinyl Urea, Yellow 5, Blue 1.
  • Principal Display Panel

    select brand
    the lower price name brand
    BURN RELIEF
    ALOE VERA GEL
    with
    LIDOCAINE
    COOLS SUNBURN PAIN
    NET WT 8 OZ( 227g)
    Z01376A0f.jpg
    Z01376A0b.jpg


  • INGREDIENTS AND APPEARANCE
    SELECT BRAND BURN RELIEF 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15127-002-16226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/19/2012
    Labeler - Select Brand Distributors (043562370)
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!