Auralyt - DailyMed Details

Auralyt

SPL v5

SPL

SPL Set ID 95920b87-941f-48cb-850c-40d2735596d4

Route

TOPICAL

Published

Effective Date 2022-02-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hydrogen Peroxide (7.8 mg)

Inactive Ingredients

Cajuput Oil Camphor (natural) Eucalyptus Oil Glycerin Menthol Methylparaben Phosphoric Acid Polysorbate 20 Propylene Glycol Sodium Stannate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-01-01

Description

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

Purpose

Earwax removal aid

Medication Information

Purpose

Earwax removal aid

Description

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

Uses

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

Section 50565-1

keep out of reach of children.

Section 51945-4

Active Ingredient

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

Other 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

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

Questions Or Comments?

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

Avoid Contact With Eyes

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.

If Pregnate Or Breast Feeding

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.

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.

Structured Label Content

Uses

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

Section 50565-1 (50565-1)

keep out of reach of children.

Section 51945-4 (51945-4)

Purpose

Earwax removal aid

Active Ingredient

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

Other Information (Other 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 ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Avoid Contact With Eyes (AVOID CONTACT WITH EYES)

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.

If Pregnate Or Breast Feeding (if pregnate or breast-feeding)

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

Advanced Ingredient Data

[{"name": "CAJUPUT OIL", "unii": "J3TO6BUQ37", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (NATURAL)", "unii": "N20HL7Q941", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHOSPHORIC ACID", "unii": "E4GA8884NN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STANNATE", "unii": "NJ7C1V83KG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "ACTIB", "strengthNumerator": "7.8", "strengthDenominator": "12", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for occasional use as an aid to soften, loosen and remove excessive earwax", "50565-1": "keep out of reach of children.", "Purpose": "Earwax removal aid", "Active Ingredient": "Carbamide Peroxide 6.5%...........Earwax removal aid", "Other 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": "Cajeput oil, camphor, eucalyptus oil, glycerin, menthol, methlyparaben, phosphoric acid, polysorbate 20, propylene glycol, sodium stannate, water", "Questions or comments?": "1-800-560-5223 M-F from 9 AM to 4 PM Eastern.", "AVOID CONTACT WITH EYES": "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.", "if pregnate or breast-feeding": "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.": "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:35.838641 · Updated: 2026-03-14T23:09:28.158875