DEBROX SWIMMERS EAR- isopropyl alcohol liquid 
Medtech Products Inc.

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.

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Debrox Swimmers Ear

Drug Facts

Active ingredient

Purpose

Isopropyl alcohol 95% in an anhydrous glycerin 5% base ....Ear drying aid

Use

dries water in the ears and relieves water-clogged ears after

Warnings

Flammable: Keep away from fire or flame

Do not use

in the eyes

Ask a doctor before use if you have

ear drainage or discharge

• ear pain, irritation or rash in the 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.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

Inactive

Glycerin

Questions?

1-800-344-7239 debrox.com

PRINCIPAL DISPLAY PANEL

Debrox ® Swimmer’s Ear

Isopropyl alcohol 95%

Ear Drying Drops

1 FL OZ (30 mL)

PRINCIPAL DISPLAY PANEL

Debrox ® Swimmer’s Ear
Isopropyl alcohol 95%
Ear Drying Drops
1 FL OZ (30 mL)

DEBROX SWIMMERS EAR 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-323
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL95 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorWHITE (CLEAR) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-323-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34404/01/2019
Labeler - Medtech Products Inc. (122715688)

Revised: 12/2019
Document Id: d79bbec9-337d-4d9c-91a9-65202e016d25
Set id: b5d57c7b-8315-4260-967e-38fdd54e2a9c
Version: 1
Effective Time: 20191225
 
Medtech Products Inc.