Label: INSTANT EAR DRY EQUATE- isopropyl alcohol solution/ drops

  • 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 2, 2018

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  • Active ingredient                         Purpose

    ISOPROPYL ALCOHOL             95.0%

  • PURPOSE

  • INDICATIONS & USAGE

    Uses
    Dries water in the ears and relieves water-clogged ears, thereby relieving discomfort, the sensation of fullness or hearing impairment

  • Warnings

    Flammable. Keep away from fire or flame

    Do not use • in the eyes

    Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness •  recently had ear surgery

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children
    If product is swallowed, get medical help or contact a Poison Control Center right away
    In case of accidental ingestion, seek professional or contact a Poison Control Center immediately.

  • Direction

    Apply 4-5 drops in each affected ear

  • Inactive ingredient

    ISOPROPYL ALCOHOL, GLYCERIN

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    INSTANT EAR DRY   EQUATE
    isopropyl alcohol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.95 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-033-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/29/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34405/29/2014
    Labeler - WalMart (051957769)
    Registrant - Product Quest (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest927768135manufacture(49035-033) , label(49035-033)
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