MedPath

Hydrogen Peroxide

Rexall 871.001/871AA 3% Hydrogen Peroxide

Approved
Approval ID

3c823b47-2ab7-4002-9b6f-abf0a3176b44

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Old East Main CO.

DUNS: 068331990

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 Code55910-871
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Hydrogen Peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (2)

HYDROGEN PEROXIDEActive
Quantity: 30 mg in 1 mL
Code: BBX060AN9V
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

principal display panel

Since 1903

Rexall™

Hydrogen Peroxide

Topical Solution USP

3% H 20 2

First Aid Antiseptic

Oral Debriding Agent

  • For treatment of minor cuts and abrasions

Do not use if printed seal under cap is broken or missing

32 FL OZ (1 QT) 946 mL

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/12/2025

Uses

  • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
  • aids in the removal of phlegm, mucous or other secretions associated with occasional sore mouth

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 8/12/2025

adverse reactions

Distributed by: Old East Main Co.

100 MISSION RIDGE GOODLETTSVILLE, TN 37072

Pat. D675, 101

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/12/2025

Active ingredient

Hydrogen peroxide (stabilized) 3%

Purpose

First aid antiseptic

Oral debriding agent

WARNINGS SECTION

LOINC: 34071-1Updated: 8/12/2025

Warnings

For external use only

Do not use

  • in the eyes or apply over large areas of the body
  • longer than 1 week

As a doctor before use if you have

deep or puncture wounds, animal bites or serious burns

Stop use and ask a doctor if

  • the condition persists or gets worse
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

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: 8/12/2025

Directions

First aid antiseptic:

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

**Oral debriding agent (oral rinse):**adults and children 2 years of age and over:

  • mix with an equal amount of water

  • swish around in the mouth over the affected area for at least 1 minute and then spit out

  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

  • children under 12 years of age should be supervised in the use

  • children under 2 years of age: consult a dentist or doctor

GENERAL PRECAUTIONS SECTION

LOINC: 34072-9Updated: 8/12/2025

Other information

keep tightly closed and at controlled room temperature. Do not shake bottle. Hold away from face when opening.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/12/2025

Inactive ingredient

purified water

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Hydrogen Peroxide - FDA Drug Approval Details