Debrox Swimmers Ear: Package Insert and Label Information

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.

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

W arnings

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)

PRINCIPAL DISPLAY PANEL

Debrox ® Swimmer’s Ear
Isopropyl alcohol 95%
Ear Drying Drops
1 FL OZ (30 mL)
(click image for full-size original)
DEBROX SWIMMERS EAR
isopropyl alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-323
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 95 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
Product Characteristics
Color WHITE (CLEAR) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-323-01 30 mL in 1 BOTTLE None
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)

Revised: 12/2019 Medtech Products Inc.

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