EAR DROPS- carbamide peroxide 6.5% liquid 
Bionpharma Inc.

----------

ear drops

Active ingredients

Carbamide Peroxide 6.5% non USP*

*pH differs from USP specifications

Purposes

Earwax removal aid

Uses

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

Warnings

Do not use

  • if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy; consult a doctor
  • If you have an injury or perforation (hole) of the ear or after ear surgery, unless directed by a doctor
  • for more than 4 consecutive days. If excessive earwax remains after use of this product, consult a doctor.

When using this product

avoid contact with eyes
Stop use and ask a doctor

  • you need to use for more than four days
  • excessive earwax remains after a four day treatment with this product

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

FOR USE IN THE EAR ONLY
Remove any earing aids before use

Adults and children over 12 yrs of age: tilt head to the side and place 10 drops into the ear.

Children under 12 yrs of age: Consult a physician.

Other information

Inactive ingredients

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Purified Water.

Questions & comments?

call toll free 1-888-235-2466
(Mon - Fri 9AM - 5PM EST)

a+health™

ear drops
carbamide
peroxide 6.5%

earwax
removal aid

SEALED FOR YOUR

PROTECTION.

DO NOT USE IF

SHRINKBAND

ON BOTTLE IS

BROKEN OR MISSING

AT TIME OF

PURCHASE.

*This product is not manufactured
or distributed by Prestige Brands
Inc., owner of the registered
trademark Debrox ®
.

DISTRIBUTED BY:
Bionpharma Inc., Princeton, NJ 08540

L0000592

R0422

Carton labeling

*compare to the active ingredient
in Debrox® Ear Drops

twin pack

a+health™

ear drops
carbamide
peroxide 6.5%

earwax removal aid


safe, gentle, non-irritating
easily cleanses ear with
microfoam action

1 fl oz (30mL)
two bottles 0.5 fl oz (15 mL) each

Carton

EAR DROPS 
carbamide peroxide 6.5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-377
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE0.065 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM STANNATE (UNII: NJ7C1V83KG)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69452-377-952 in 1 CARTON09/15/2022
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:69452-377-751 in 1 CARTON09/15/2022
215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01409/15/2022
Labeler - Bionpharma Inc. (079637826)
Registrant - Bionpharma Inc. (079637826)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114manufacture(69452-377) , pack(69452-377)

Revised: 12/2024
Document Id: 29f92230-d1d9-5e94-e063-6294a90af812
Set id: e8bcf92c-ad32-49d5-e053-2995a90ae0c6
Version: 3
Effective Time: 20241223
 
Bionpharma Inc.