Ear Drops

Manufacturer
REMEDYREPACK INC.
Effective date
2021-01-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:57:28

Label at a glance#

ProductEar Drops Major
Active ingredientCARBAMIDE PEROXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide 6.5%

OTC - PURPOSE SECTION

Earwax Removal Aid

INDICATIONS & USAGE SECTION

For occasional use as an aid to soften. loosen and remove excessive earwax.

WARNINGS SECTION

Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery

When using this product avoid contact with eyes

Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product

Stop use and ask a doctor if ​you need to use for more than four days • excessive earwax remains after use of this product

Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

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.

INACTIVE INGREDIENT SECTION

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Ear DropsMajor Major

GENERIC: Carbamide Peroxide 6.5%

DOSAGE: LIQUID

ADMINSTRATION: AURICULAR (OTIC)

NDC: 70518-0524-0

NDC: 70518-0524-1

PACKAGING: 15 mL in 1 BOTTLE

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

  • CARBAMIDE PEROXIDE 6.5g in 100mL

INACTIVE INGREDIENT(S):

  • SODIUM STANNATE
  • GLYCERIN
  • ANHYDROUS CITRIC ACID
  • PROPYLENE GLYCOL
  • SODIUM LAUROYL SARCOSINATE
  • WATER

Remedy_LabelRemedy_Label

MM2MM2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6627-35ML - Milliliter0904-6627961d332f-97a9-4b3c-bf08-36c272f4485712017-08-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-052470518-0524-1, 70518-0524-0
0904-6627

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e4a47131-8018-3d92-e053-2a95a90a619e465f62ef-38d5-4bca-8659-dedcef119ac52022-07-25WarningsExact identifier
spl set id: 465f62ef-38d5-4bca-8659-dedcef119ac5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.