EAR DROPS- carbamide peroxide 6.5% liquid 
Bionpharma 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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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 finalM01409/15/2022
Labeler - Bionpharma Inc. (079637826)
Registrant - Bionpharma Inc. (079637826)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114manufacture(69452-377) , pack(69452-377)

Revised: 1/2023
Document Id: f383c4d4-d788-59e7-e053-2a95a90af26f
Set id: e8bcf92c-ad32-49d5-e053-2995a90ae0c6
Version: 2
Effective Time: 20230130
 
Bionpharma Inc.