DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Hydrogen Peroxide (6.5 g)

Inactive Ingredients

Tartaric Acid Glycerin Citric Acid Monohydrate Sodium Citrate Sodium Lauryl Sulfate Propylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-12-12

Medication Information

Warnings and Precautions

Ask a doctor before use if you have

• ear drainage or discharge

• ear pain

• irritation or rash in the ear

• dizziness

• an injury or perforation (hole) of the ear drum

• recently had ear surgery

Indications and Usage

For occasional use as an aid to soften, loosen and remove excessive ear wax

Description

Carbamide Peroxide 6.5%

Section 44425-7

• Avoid exposing bottle to excessive heat or direct sunlight.

• Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling

• Keep cap on bottle when not in use.

• Lot no. and exp. date:see Label, bottom contained or box.

Section 50565-1

Keep out of reach of children.In case of accidental overdose or allergic

reaction, get medical help or contact a Posion Control Center immediately

Section 50566-9

Stop use and ask a doctor if

• you need to use for more than 4 days

• excessive ear wax remains after use of this product

Section 50567-7

When using this productdo not get into eyes

Section 51727-6

Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

Section 51945-4

WaxRx

EAR WAX

REMOVAL

AID DROPS

6.5% Carbamide Peroxide

Safe, Fast Acting

Alcohol Free

0.5 FL OZ (15 ML)

Section 55105-1

Carbamide Peroxide 6.5%...................Earwax Removal Aid

Section 55106-9

Carbamide Peroxide 6.5%

For Use in the Ear Only

Adults and children over 12 years of age.Tilt head sideways and place 5-10 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 ears. Flush ear with VERY WARM (body temperature) water using the Wax-Rx Ear Washer.

Children under 12, consult a physician. Drops my be used twice daily for up to 4 days or as directed by a physician.

Structured Label Content

Indications and Usage (34067-9)

For occasional use as an aid to soften, loosen and remove excessive ear wax

Warnings and Precautions (34071-1)

Ask a doctor before use if you have

• ear drainage or discharge

• ear pain

• irritation or rash in the ear

• dizziness

• an injury or perforation (hole) of the ear drum

• recently had ear surgery

Section 44425-7 (44425-7)

• Avoid exposing bottle to excessive heat or direct sunlight.

• Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling

• Keep cap on bottle when not in use.

• Lot no. and exp. date:see Label, bottom contained or box.

Section 50565-1 (50565-1)

Keep out of reach of children.In case of accidental overdose or allergic

reaction, get medical help or contact a Posion Control Center immediately

Section 50566-9 (50566-9)

Stop use and ask a doctor if

• you need to use for more than 4 days

• excessive ear wax remains after use of this product

Section 50567-7 (50567-7)

When using this productdo not get into eyes

Section 51727-6 (51727-6)

Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

Section 51945-4 (51945-4)

WaxRx

EAR WAX

REMOVAL

AID DROPS

6.5% Carbamide Peroxide

Safe, Fast Acting

Alcohol Free

0.5 FL OZ (15 ML)

Section 55105-1 (55105-1)

Carbamide Peroxide 6.5%...................Earwax Removal Aid

Section 55106-9 (55106-9)

Carbamide Peroxide 6.5%

For Use in the Ear Only (FOR USE IN THE EAR ONLY)

Adults and children over 12 years of age.Tilt head sideways and place 5-10 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 ears. Flush ear with VERY WARM (body temperature) water using the Wax-Rx Ear Washer.

Children under 12, consult a physician. Drops my be used twice daily for up to 4 days or as directed by a physician.

Advanced Ingredient Data

[{"name": "TARTARIC ACID", "unii": "W4888I119H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "ACTIB", "strengthNumerator": "6.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "For occasional use as an aid to soften, loosen and remove excessive ear wax", "34071-1": "Ask a doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in the ear • dizziness • an injury or perforation (hole) of the ear drum • recently had ear surgery", "44425-7": "• Avoid exposing bottle to excessive heat or direct sunlight. • Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling • Keep cap on bottle when not in use. • Lot no. and exp. date:see Label, bottom contained or box.", "50565-1": "Keep out of reach of children. In case of accidental overdose or allergic reaction, get medical help or contact a Posion Control Center immediately", "50566-9": "Stop use and ask a doctor if • you need to use for more than 4 days • excessive ear wax remains after use of this product", "50567-7": "When using this product do not get into eyes", "51727-6": "Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid", "51945-4": "WaxRx EAR WAX REMOVAL AID DROPS 6.5% Carbamide Peroxide Safe, Fast Acting Alcohol Free 0.5 FL OZ (15 ML)", "55105-1": "Carbamide Peroxide 6.5%...................Earwax Removal Aid", "55106-9": "Carbamide Peroxide 6.5%", "FOR USE IN THE EAR ONLY": "Adults and children over 12 years of age. Tilt head sideways and place 5-10 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 ears. Flush ear with VERY WARM (body temperature) water using the Wax-Rx Ear Washer. Children under 12, consult a physician. Drops my be used twice daily for up to 4 days or as directed by a physician."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information