Label: OIDO SANA- isopropyl alcohol solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 25, 2022

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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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