Label: AVALIN EXTERNAL ANALGESIC PATCH- lidocaine, menthol patch

  • 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 January 29, 2015

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  • Active ingredients

    Lidocaine 4%

    Menthol 1%

    Purpose

    External Analgesic

  • Uses

    For the temporary relief pain associated with • minor cuts  • scrapes  • minor skin imitations

  • Warnings

    For external use only

    Do not use

    • in large quantities, particularly over raw surfaces or blistered areas

    • other than directed by a doctor  • on open wounds or damaged skin

    • with a bandage to cover the surface  • for longer than 5 consecutive days

    Ask a doctor before use

    if used for children under 12.

    When using this product

    avoid contact with the eyes.

    Stop use and ask a doctor

    • condition worsens  • symptoms persist for more than 7 days

    • symptoms clear up and occur again within a few days

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    • Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: Consult a doctor.
    • Clean and dry affected area.
    • Remove patch from backing and apply to affected area.
    • Use one patch at a time.
    • Leave patch on affected area for up to 8-hours at a time
  • Other information

    Store in dry area between 59-79 F(15-26 C)

  • Inactive ingredients

    acrylic acid, aluminum hydroxide, carmellose sodium, 2-ethylhexyl acrylate, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylate, polyacrylic acid, polysorbate 80, sorbitan sesquioleate, starch, talc, tartaric acid, titanium dioxide, water

  • Questions or comments?

    Please call (818) 545-1177

  • Product Label

    FrontPanelDrugFacts

  • INGREDIENTS AND APPEARANCE
    AVALIN EXTERNAL ANALGESIC PATCH 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33358-901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33358-901-1515 in 1 CARTON
    1100 g in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/29/2015
    Labeler - RxChange Co. (781126805)
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