EAR ITCH MD (PRAMOXINE HYDROCHLORIDE) SPRAY [EOSERA INC]

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EAR ITCH MD (PRAMOXINE HYDROCHLORIDE) SPRAY [EOSERA INC]
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NDC 72429-0071-5
Set ID d4ea80e7-3452-44dd-a1eb-f3805d91bdfa
Category HUMAN OTC DRUG LABEL
Packager Eosera Inc
Generic Name
Product Class
Product Number
Application Number PART348
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  • WARNINGS

  • Active Ingredient

    Pramoxine HCl 1%

  • Purpose

    Topical anethetic

  • Uses

    For the temporary relief of itching associated with minor skin irritations

  • Warnings

    • Keep out of reach of children
    • 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 to 4 times daily or as directed by your doctor
    Children under 2 years of age: Consult a doctor

  • Other Information

    Store at room temperature

  • Inactive ingredients

    Aloe barbadensis (Aloe), Benzalkonium chloride, Benzyl alcohol, Glycerin, Propylene glycol, water

  • Principle Display

    image description

  • INGREDIENTS AND APPEARANCE
    EAR ITCH MD 
    pramoxine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72429-0071
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 5 g  in 100 mL
    Glycerin (UNII: PDC6A3C0OX) 0.4 g  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.4 g  in 100 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.35 g  in 100 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) 0.01 g  in 100 mL
    water (UNII: 059QF0KO0R) 92.84 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72429-0071-515 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2019
    Labeler - Eosera Inc (079789050)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eosera Inc079789050manufacture(72429-0071)
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