DEBROX SWIMMERS EAR- isopropyl alcohol liquid

Debrox Swimmers Ear by

Drug Labeling and Warnings

Debrox Swimmers Ear by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• swimming
  
• showering
  
• bathing
  
• washing the hair

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

• unscrew cap from bottle
  
• remove foil safety seal from bottle
  
• affix applicator cap to bottle
  
• remove red applicator cap tip
  
• apply 4 to 5 drops in each affected ear

Other information

• recap bottle after each use
  
• keep away from head or direct sunlight
  
• store at room temperature 15-25ºC (59-77ºF)
  
• do not use if foil seal imprinted with “SEALED FOR YOUR PROTECTION” under cap is broken or missing
  
• keep carton for full drug facts

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)

INGREDIENTS AND APPEARANCE

DEBROX SWIMMERS EAR 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-323
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	95 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	WHITE (CLEAR)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-323-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part344	04/01/2019

Labeler - Medtech Products Inc. (122715688)