42a22e06-1b66-4359-852c-7c39e1b3940a

Set ID
42a22e06-1b66-4359-852c-7c39e1b3940a
Manufacturer
CVS Pharmacy, Inc.
Effective date
2024-06-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:23

Key Label Information

Active Ingredients And Purpose

Active ingredient

Carbamide peroxide 6.5%

Uses

Uses

for occasional use as an aid to soften, loosen, and remove excessive earwax

Warnings

Warnings

For use in the ear only

Directions And Dosage

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: consult a doctor

Other Label Information

Inactive ingredients

anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

Questions?

1-800-328-5890 Weekdays 8:30-5:00 CST

Package Labeling:

Products

NDC Codes

Ingredients

NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB

Complete SPL Sections

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Carbamide peroxide 6.5%

Uses

INDICATIONS & USAGE SECTION

for occasional use as an aid to soften, loosen, and remove excessive earwax

Warnings

WARNINGS SECTION

For use in the ear only

Directions

DOSAGE & ADMINISTRATION SECTION

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: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

Avoid exposing bottle to excessive heat and direct sunlight Store bottle in the outer carton Store at 15-30ºC (59-86ºF) Keep cap on bottle when not in use Product foams on contact with earwax due to release of oxygen. There may be an associated crackling sound. Do not use if tamper-evident safety seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

Questions?

OTC - QUESTIONS SECTION

1-800-328-5890 Weekdays 8:30-5:00 CST

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/42a22e06-1b66-4359-852c-7c39e1b3940a/1ba4260c-f726-77de-e063-6294a90ab529.xml
XML SHA-256
e05ae4fb200d67d67fd4bee179eb679af91f44ea785eca33a661a6326c772da1
XML bytes
20329

Legacy File Index

FolderFileDate
otc1ba4260c-f726-77de-e063-6294a90ab529.xml2024-08-02
otcCarton.jpg2024-08-02
otcLabel - Bottle.jpg2024-08-02