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NDC 71205-0136-15 DEBROX 65 mg/mL Details

DEBROX 65 mg/mL

DEBROX is a AURICULAR (OTIC) LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is CARBAMIDE PEROXIDE.

Product Information

NDC	71205-0136
Product ID	71205-136_61b565d3-ad7d-4ab6-931a-099f2392c9ab
Associated GPIs	87400030002010
GCN Sequence Number	008120
GCN Sequence Number Description	carbamide peroxide DROPS 6.5 % OTIC (EAR)
HIC3	Q8R
HIC3 Description	EAR PREPARATIONS,EAR WAX REMOVERS
GCN	34401
HICL Sequence Number	004272
HICL Sequence Number Description	CARBAMIDE PEROXIDE
Brand/Generic	Generic
Proprietary Name	DEBROX
Proprietary Name Suffix	n/a
Non-Proprietary Name	Carbamide Peroxide
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	AURICULAR (OTIC)
Active Ingredient Strength	65
Active Ingredient Units	mg/mL
Substance Name	CARBAMIDE PEROXIDE
Labeler Name	Proficient Rx LP
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part344
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71205-0136-15 (71205013615)

Pricing Information	N/A
NDC Package Code	71205-136-15
Billing NDC	71205013615
Package	1 BOTTLE, DROPPER in 1 CARTON (71205-136-15) / 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2018-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e1dacadf-cfb4-4a06-9858-dd6fba2975f8 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Carbamide peroxide 6.5% non USP*

*pH differs from USP specifications

Purpose

Earwax removal aid

Uses

for occasional use as an aid to soften, loosen, and remove excessive earwax

Warnings

Ask a doctor before use if you have

•: ear drainage or discharge
•: ear pain
•: irritation or rash in the ear
•: dizziness
•: an injury or perforation (hole) of the eardrum
•: recently had ear surgery

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

•: you need to use for more than four days
•: excessive earwax remains after use of this product

Keep this and all drugs out of the reach of children.

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

Directions

FOR USE IN THE EAR ONLY

adults and children over 12 years of age:

•: tilt head sideways
•: place 5 to 10 drops into ear
•: tip of applicator should not enter ear canal
•: keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear
•: use twice daily for up to four days if needed, or as directed by a doctor
•: any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe

children under 12 years: consult a doctor

Other information

•: do not store above 25C (77F)
•: store bottle in the outer carton
•: product foams on contact with earwax due to release of oxygen. There may be an associated “crackling” sound.
•: keep tip on bottle when not in use

Inactive ingredients

citric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, water

Questions or comments?

call toll-free 1-866-255-5202 Debrox.com

PRINCIPAL DISPLAY PANEL

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Debrox® DROPS

Carbamide Peroxide 6.5% Non USP*

Earwax Removal Aid

Kit includes soft rubber bulb ear syringe and drops

½ FL OZ (15mL)

INGREDIENTS AND APPEARANCE

DEBROX

carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-136(NDC:63029-322)
Route of Administration	AURICULAR (OTIC)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	65 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71205-136-15	1 in 1 CARTON	10/01/2018
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part344	06/01/2012

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	RELABEL(71205-136)

Revised: 10/2019

Document Id: 61b565d3-ad7d-4ab6-931a-099f2392c9ab

Set id: e1dacadf-cfb4-4a06-9858-dd6fba2975f8

Version: 3

Effective Time: 20191001