drug facts
Drug Labeling and Warnings
Drug Details [pdf]
EARWAX REMOVAL AID- carbamide peroxide liquid
Preferred Pharmaceuticals, 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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drug facts
Active Ingredient
Active ingredient Purpose
Carbamide Peroxide 6.5%..........................Earwax Removal Aid
Keep Out of Reach of Children
Keep out of reach of children. If swallowed, get medical help
or contact a Poison Control Center right away.
Indications and Usage
Uses for occasional use as an aid to soften, loosen and remove excessive ear wax.
Warnings
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 ear drum
- recently had ear surgery
Stop use and ask a doctor if
- you need to use for more than four days
- excessive wax remains after use of this product
When using this product - avoid contact with the eyes
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Directions
Directions
FOR USE IN THE EAR ONLY
Unscrew cap from bottle. Remove foil safety seal from bottle. Affix applicator cap to bottle.
Adults and children over 12 years of age:
- tilt head sideways and 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 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 ear syringe.
Children under 12 years of age: consult a doctor.
Other information
- avoid exposing the bottle to excessive heat and direct sunlight
- keep cap on bottle when not in use
- Note: Drops foam on contact with ear wax due to release of oxygen. There may be an associated "cracking" sound
- Note: Oversize packaging for ease in reading label information. Contains one bottle.
- Store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
Inactive Ingredients
Inactive ingredients
anhydrous glycerin, citric acid, propylene glycol, sodium lauryl sulfate, sodium citrate, tartaric acid
Principal Display Panel
NDC: 68788-0225-1
EAR DROPS
Earwax Removal Aid
(carbamide peroxide 6.5%)
Distributed by:
MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA
Relabeled By: Preferred Pharmaceuticals, Inc.
| EARWAX REMOVAL AID
carbamide peroxide liquid |
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| Labeler - Preferred Pharmaceuticals, Inc. (791119022) |
| Registrant - Preferred Pharmaceuticals, Inc. (791119022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Preferred Pharmaceuticals, Inc. | 791119022 | RELABEL(68788-0225) | |