OTC Medication Information: Ear Wax Removal Drops
EAR WAX REMOVAL DROPS- carbamide peroxide solution/ drops
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.
Active ingredient
Carbamide Peroxide, 6.5%
Earwax removal aid
Uses
For occasional use as an aid to soften, loosen and remove excessive ear wax.
Warnings
Do not use if you have
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- eardrainage, discharge, ear pain,irritation
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- rashin the ear,or are dizzy
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- injuryor perforation (hole) of the ear drum or after ear surgery
When using this product
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- do not use for more than four days
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- avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor
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- if excessive earwax remains after the use of this product, consult a doctor
Keep 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
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- Adults and children over 12 years of age :
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- Tilt head sideways and place 5 to 10 drops into ear.
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- Tip of applicator should not enter ear canal.
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- Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear.
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- Use twice daily for up to 4 days if needed, or as directed by a doctor.
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- Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
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- When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.
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- Children under 12 years : consult a doctor.
Other information
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- Protect from heat and direct sunlight
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- Keep cap on bottle when not in use.
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- Lot No. and EXP date: see label, bottom container or box.
- NDC 68788-7496-01 1 Bottle .5FL OZ
Relabeled by Preferred Pharmaceuticals, Inc.
Inactive ingredients
Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid
Principal Display Panel Bottle Label 0.5 FL OZ
Preferred Plus Pharmacy
Ear Wax Removal drops
Carbamide Peroxide 6.5%
0.5 FL OZ (15ml)
- NDC: 68788-7498-01 Bottle .5 FL OZ
Relabeled by Preferred Pharmaceuticals, Inc.
EAR WAX REMOVAL DROPS carbamide peroxide — 6.5% solution/ drops | |||||||||||||||||
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Labeler — Preferred Pharmaceuticals, Inc. (791119022) |
Registrant — Preferred Pharmaceuticals, Inc. (791119022) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Preferred Pharmaceuticals, Inc. | 791119022 | RELABEL (68788-7498) |
Revised: 03/2020 Preferred Pharmaceuticals, Inc.
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.
https://otclabels.com/lib/otc/otc-meds/ear-wax-removal-drops-3/