Label: DUANE READE ALOE VERA PAIN RELIEVING- lidocaine 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 14, 2012

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

View All Sections
  • Active Ingredients

    Lidocaine 0.50%
    Menthol  0.10%
  • Purpose

    Topical Analgesic

  • 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

    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 or if symptoms persists for more than 7 days.
    • symptoms clear up and occur 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.apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: do not use, ask a doctor.
  • Inactive Ingredients

    Water, Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Propylene Glycol, Glycerin, Polysorbate 20, Carbomer, Triethanolamine, Diazolidinyl urea, Disodium EDTA, Tocopherol, Blue 1.

  • Principal Display Panel

    UNIQUELY NY DRTM SINCE 1960

    aloe
    vera

    pain relieving gel
    with Lidocaine and Menthol

    NET WT 16 OZ (454 g)
    ZDR011A0.jpg


  • INGREDIENTS AND APPEARANCE
    DUANE READE ALOE VERA  PAIN RELIEVING
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67732-408
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.5 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67732-408-19454 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/23/2012
    Labeler - DUANE READE INC. (011988995)
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!