Active Ingredients
Carbamide Peroxide 6.5% non USP*
*pH differs from USP specifications
Ear Drops Liquid
FDA Label NDC 69452-377
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bionpharma Inc. for the product Ear Drops (NDC 69452-377). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purposes, uses, warnings, do not use, when using this product, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - Keep Out Of Reach Of Children
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.
- Tip of applicator should not enter into the ear canal
- Keep drops in ear for several minutes by keeping head tilted sideways or placing cotton in the ear.
- Use twice daily for up to 4 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 yrs of age: Consult a physician.
Other Information
- do not store above 77°F (25°C)
- store bottle in outer carton
- product foams on contact with ear was due to the release of oxygen. There may be an associated “crackling” sound.
- keep cap on bottle when not in use
Inactive Ingredients
Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Purified Water.
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Other
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 (Carton)
* Please review the disclaimer below.
