EAR PAIN MD (PAIN RELIEF DROPS) SOLUTION/ DROPS [EOSERA INC]

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EAR PAIN MD (PAIN RELIEF DROPS) SOLUTION/ DROPS [EOSERA INC]
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NDC 72429-0070-8
Set ID 6a36337c-8357-4585-b4e5-879ce2224a40
Category HUMAN OTC DRUG LABEL
Packager Eosera Inc
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • Active Ingredient

    Lidocaine Hydrochloride - 4%

  • Purpose 

    Topical analgesic

  • Uses

    For the temporary relief of pain

  • KEEP OUT OF REACH OF CHILDREN

  • Warnings:

    For external use only
    Do not ingest
    Avoid contact with eyes
    If conditions worsen, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
    Do not use in large quantities, particularly over raw surfaces or blistered areas
    Do not use if you are allergic to any ingredient in this product

  • Directions

    Consult your doctor before use. Adults and children 2 years of age and older: Apply to affected area not more than 3-4 times daily or as directed by your doctor.
    Children under 2 years of age: consult a doctor

  • Other Information

    Store at room temperature (20-25o C, 68-77o F)

  • Inactive Ingredients

    Water, Aloe barbadensis (Aloe), Glycerin, Propylene glycol, Benzalkonium chloride

  • Package label

    Front and back panel

  • INGREDIENTS AND APPEARANCE
    EAR PAIN MD  
    pain relief drops solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72429-0070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Glycerin (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72429-0070-815 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2018
    Labeler - Eosera Inc (079789050)
    Registrant - Eosera Inc (079789050)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eosera Inc079789050manufacture(72429-0070) , label(72429-0070)
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