GREENCAINE BLAST (LIDOCAINE) GEL [ALMA LABORATORIES, INC.]

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GREENCAINE BLAST (LIDOCAINE) GEL [ALMA LABORATORIES, INC.]
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NDC 69747-040-01
Set ID 031e0065-4c8a-43d8-bc69-3efa3c6c0ae3
Category HUMAN OTC DRUG LABEL
Packager ALMA Laboratories, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • Drug Facts

    Lidocaine 4%

  • Active Ingredient

    Lidocaine 4%

    Purpose

    Topical Anesthetic

  • Uses

    For the temporary relief of pain and itching associated with minor skin irritations, minor cuts, minor burns, scrapes or insect bites.

  • Warnings

    For external use only

    Flammable

    Keep away from heat, sparks, electrical, fire or flame.

    When using this product

    avoid contact with the 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 or clear up and occur again within a few days, discontinue use of this product.

    Keep out of the reach of children

    If swallowed, get medical helo 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 times daily. Children under 2 years of age consult a doctor.

  • Inactive ingredients:

    Aloe barbadensis leaf juice (aloe vera), caprylyl glycol, carbomer, disodium EDTA, glycerin, glyceryl laurate, jojoba oil, SD alcohol 40-B, trithanolamine, water.

  • Questions:

    Call (888) 306-6933 or visit www.greencaine.com

  • Package Labeling

    Label 1Label 2

  • INGREDIENTS AND APPEARANCE
    GREENCAINE BLAST 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69747-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69747-040-01113 g in 1 TUBE; Type 0: Not a Combination Product01/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/18/2018
    Labeler - ALMA Laboratories, Inc. (012180032)
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