OIDO SANA (ISOPROPYL ALCOHOL) SOLUTION [PROMEX LLC]

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OIDO SANA (ISOPROPYL ALCOHOL) SOLUTION [PROMEX LLC]
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NDC 58988-1100-1
Set ID 71e84695-49e8-459f-ac5e-118b5235fe06
Category HUMAN OTC DRUG LABEL
Packager ProMex LLC
Generic Name
Product Class
Product Number
Application Number PART344
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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active Ingredients:Purpose
    Isopropyl alcohol 95%Ear drying aid
    Anhydrous glycerin 5% baseEar drying aid
  • Uses

    dries water in the ears

  • Warnings

    Flammable: Keep away from fire and flame

    Use only in a well ventilated area; fumes may be toxic.

    Ask a doctor before use if you have

    • Ear drainage or discharge
    • Pain, irritation or rash in the ear
    • Had ear surgery
    • Dizziness

    Stop use and ask a doctor if irritation (too much burning) or pain occurs

    Keep out of reach of children.

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

  • Directions

    remove safety seal from bottle, apply 4 to 5 drops in each affected ear.

  • Other information

    • Recap bottle after each use
    • Keep away from heat or direct sunlight
    • Store at room temperature
    • Do not use if safety seal is damaged or missing prior to first use
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    OIDO® SANA

    Pro-Mex®

    Fast Relief for

    Ears

    1 fl oz (30 mL)

    Principal Display Panel - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    OIDO SANA 
    isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-1100
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.95 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.05 g  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58988-1100-11 in 1 CARTON05/31/2006
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34405/31/2006
    Labeler - ProMex LLC (789974388)
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