FDA label e5cf4aca-10a7-4eb4-9486-60ea3653aaa7

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
b64fecbb-e96e-47fd-96fe-290fd2316576
SPL ID
e5cf4aca-10a7-4eb4-9486-60ea3653aaa7
Version
3
Effective date
2018-02-21
Source export date
2026-08-01
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/054d07cb7b0dcd436e53c5bdecbb921b48860de8ff372c4a586941aa9821a276/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:20:43

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only Keep out of reach of the children If product is swallowed, get medical help or contact a Poison Control Center right away Directions For use in the ear only. 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 bulb ear syringe ​Children under 12 years of age: consult a doctor. Other information • Protect from heat and direct sunlight • Keep cup on bottle when not in use Inactive ingredient Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Oxyquinoline Sulfate Questions or comments? 1-866-483-2846