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Xpect Hydrogen Peroxide

Xpect Hydrogen Peroxide

Approved
Approval ID

793afae4-5270-4be7-b41a-269b4e59bcad

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 23, 2025

Manufacturers
FDA

Cintas Corporation

DUNS: 056481716

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42961-216
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Hydrogen Peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 23, 2025
FDA Product Classification

INGREDIENTS (2)

HYDROGEN PEROXIDEActive
Quantity: 3 mL in 100 mL
Code: BBX060AN9V
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/23/2025

Package Principal Display Panel

HYDROGEN

PEROXIDE

First Aid Antiseptic

Irrigates & Cleanses Wounds

Convenient pump spray allows no-touch application. Use as a first aid treatment for minor cuts, scrapes and abrasions.

2 fl. oz. (59.1 mL)

**Xpect®**First aid

bottle-label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/15/2022

Uses

first aid to help prevent infection in minor cuts, scrapes and burns

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/23/2025

Active ingredients

Hydrogen Peroxide topical solution U.S.P. 3%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/15/2022

Purpose

First Aid Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 8/15/2022

Warnings

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/15/2022

Do not use

  • in the eyes or apply over large areas of the body

  • longer than 1 week unless directed by a doctor

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 8/15/2022

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/15/2022

Stop use and ask a doctor if

  • condition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/15/2022

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/16/2022

Directions

  • clean the affected area
  • spray a small amount 1 to 3 times daily
  • may be covered with a sterile bandage.
  • if bandaged, let dry first

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/15/2022

Other information

  • store at room temperature

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/15/2022

Inactive Ingredients

  • purified water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/15/2022

Questions?

1-877-973-2811 M-F 8am-5pm

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Xpect Hydrogen Peroxide - FDA Drug Approval Details