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Quality Choice Hydrogen Peroxide Wipes

Quality Choice 3% Hydrogen Peroxide Wipes

Approved
Approval ID

c2822eb6-8a2a-4337-acce-6f7fc8496175

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 26, 2025

Manufacturers
FDA

Chain Drug Marketing Association, Inc

DUNS: 011920774

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

HYDROGEN PEROXIDE

PRODUCT DETAILS

NDC Product Code83324-290
Application NumberM003
Marketing CategoryC200263
Route of AdministrationTOPICAL
Effective DateMay 26, 2025
Generic NameHYDROGEN PEROXIDE

INGREDIENTS (3)

POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROGEN PEROXIDEActive
Quantity: 30 mg in 1 g
Code: BBX060AN9V
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/21/2025

Package Labeling:

Label0

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/21/2025

Uses

first aid to help reduce the risk of infection in:
• minor cuts • scrapes • burns

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/21/2025

Other information

  • do not apply internally • keep canister tightly closed and stored at room temperature • hold away from face when opening

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/21/2025

Active ingredient

Hydrogen peroxide (stabilized) 3%

Purpose

First aid antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 5/21/2025

Warnings

For external use only.

Ask a doctor before use if you have

• deep or puncture wounds • animal bites • serious burns

When using this product

• do not get in eyes • do not apply over large areas

• do not use longer than 1 week unless directed by a doctor

Stop use and ask doctor if

condition persists or gets worse.

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/21/2025

Directions

• clean the affected area • apply product on the affected area of the body 1 to 3 times a day • may be covered with a sterile bandage • if bandaged, let dry first

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/21/2025

Inactive ingredients:

polysorbate 80, purified water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/21/2025

Questions or comments?

1-800-935-2362

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Quality Choice Hydrogen Peroxide Wipes - FDA Drug Approval Details