Auralyt

Manufacturer: Menper Distributors, Inc | Rnv LLC
Effective date: 2025-07-22
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 01:08:20

Label at a glance#

ProductAuralyt

Active ingredientCARBAMIDE PEROXIDE

Label structure11 sections

Indications and uses

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

Dosage and administration

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 soft ruber bul...

Contacts and useful links#

PhoneLabel contact1-800-560-5223

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide 6.5%...........Earwax removal aid

Purpose

OTC - PURPOSE SECTION

Earwax removal aid

Uses

INDICATIONS & USAGE SECTION

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

AVOID CONTACT WITH EYES

WARNINGS SECTION

Do not use :

if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy, consult a doctor
if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor
for more than 4 days; if excessive ear wax remains after use of this product, consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children.

if pregnate or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

In case of accidental indegestion, get medical help or contact a Poison Control Center right away.

Directions FOR USE IN THE EAR ONLY.

DOSAGE & ADMINISTRATION SECTION

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 soft ruber bulb ear syringe.
Children under 12 years of age: consult a doctor.

Other information

OTHER SAFETY INFORMATION

Store this product between 15° to 30° C (59°-86° F)
Tamper-Evident Feature: Do not use this product if imprinted safety seal over bottle cap is torn, broken, or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cajeput oil, camphor, eucalyptus oil, glycerin, menthol, methlyparaben, phosphoric acid, polysorbate 20, propylene glycol, sodium stannate, water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-560-5223 M-F from 9 AM to 4 PM Eastern.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53145-311-04	2023-07-28	C162847	48780-1	9d75b9d0-5992-f424-e053-dadaa90a57ce	Auralyt
53145-311-04	2022-02-18	C162847	48780-1	9d75b9d0-5992-f424-e053-dadaa90a57ce	Auralyt
53145-311-04	2022-01-28	C162847	48780-1	9d75b9d0-5992-f424-e053-dadaa90a57ce	Auralyt
53145-311-04	2020-02-04	C162847	48780-1	9d75b9d0-5992-f424-e053-dadaa90a57ce	Auralyt
53145-311-04	2020-01-31	C162847	48780-1	9d75b9d0-5992-f424-e053-dadaa90a57ce	Auralyt

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53145-311-04	Auralyt	12 mL in 1 BOTTLE, DROPPER	LIQUID	12		5
53145-311-04	Auralyt	1 in 1 CARTON	LIQUID	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CARBAMIDE PEROXIDE	ACTIVE INGREDIENT	31PZ2VAU81	1
HYDROGEN PEROXIDE	ACTIVE MOIETY	BBX060AN9V	1
CAMPHOR (NATURAL)	INACTIVE INGREDIENT	N20HL7Q941	1
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SODIUM STANNATE	INACTIVE INGREDIENT	NJ7C1V83KG	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Auralyt
Carbamide Peroxide
CAJUPUT OIL
CAMPHOR (NATURAL)
EUCALYPTUS OIL
GLYCERIN
MENTHOL
METHYLPARABEN
PHOSPHORIC ACID
POLYSORBATE 20
PROPYLENE GLYCOL
SODIUM STANNATE
WATER
HYDROGEN PEROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53145-311	53145-311-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CAJUPUT OIL	J3TO6BUQ37	IACT
CAMPHOR (NATURAL)	N20HL7Q941	IACT
EUCALYPTUS OIL	2R04ONI662	IACT
GLYCERIN	PDC6A3C0OX	IACT
MENTHOL	L7T10EIP3A	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM STANNATE	NJ7C1V83KG	IACT
WATER	059QF0KO0R	IACT
CARBAMIDE PEROXIDE	31PZ2VAU81	ACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 118 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii+route 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii+route 46 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii+route 46 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	EMULSION / TOPICAL	2 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	GEL / TOPICAL	ADJ PH		Exact identifier — unii+route 14 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii+route 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii+route 46 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	OINTMENT / TOPICAL	ADJ PH		Exact identifier — unii+route 14 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CREAM / TOPICAL		108 mg	Exact identifier — unii+route 18 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii+route 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route 46 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii+route 46 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route 46 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii+route 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii+route 46 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / TOPICAL	3.7 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route 46 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	LOTION / TOPICAL		2000 mg	Exact identifier — unii+route 18 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	OINTMENT / TOPICAL	ADJ PH		Exact identifier — unii+route 14 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	LOTION, AUGMENTED / TOPICAL		1 mg	Exact identifier — unii+route 14 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	CREAM / TOPICAL		13 mg	Exact identifier — unii+route 14 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	GEL / TOPICAL	ADJ PH		Exact identifier — unii+route 14 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii+route 14 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	LOTION / TOPICAL	0.05 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CLOTH / TOPICAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii+route 46 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii+route 46 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii+dosage form 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii+route 46 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+dosage form 46 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii+route 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii+dosage form 46 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii+route 46 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii+route 46 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii+route 46 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii+route 46 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii+route 46 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / TOPICAL	3.7 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii+route 46 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii+dosage form 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii+route 46 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route 46 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
EUCALYPTUS OIL	EUCALYPTUS OIL	2R04ONI662	SYRUP / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route 46 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii+route 46 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii+route 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii+route 46 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Auralyt	CARBAMIDE PEROXIDE	Menper Distributors, Inc	95920b87-941f-48cb-850c-40d2735596d4	2025-07-22	Warnings	Exact identifier ndc (package): 53145-311-04 ndc (product): 53145-311 ndc11 (package): 53145031104 spl id: 3a8ad090-e1c6-7ea7-e063-6394a90a6ffc spl set id: 95920b87-941f-48cb-850c-40d2735596d4

Reported adverse events (FAERS/openFDA)#

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