MedPath

Hydrogen Peroxide

CVP 871.001/871AA 3% Hydrogen Peroxide

Approved
Approval ID

78a46975-568a-4a88-8597-9603b8bbf935

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

Salado Sales, Inc

DUNS: 009830555

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 Code57243-871
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
HYDROGEN PEROXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (2)

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

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

Principal display panel

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

CVP ®

HEALTH

HYDROGEN PEROXIDE

TOPICAL SOLUTION USP

FIRST AID ANTISEPTIC

ORAL DEBRIDING AGENT

ORAL WOUND CLEANSER

Square bottle uses less plastic than a similarly sized round bottle

Recyclable (if available in your area)

16 FL OZ (1 PT) 473 mL

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2025

Uses

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

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 8/1/2025

ADVERSE REACTION

Distributed by: Consumer Value Products, Inc.

Temple, TX 76502

CVPproducts.com

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/1/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

Active ingredient

Hydrogen peroxide (stabilized) 3%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/1/2025

Purpose

First aid antiseptic

Oral debriding agent

WARNINGS SECTION

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

Warnings

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/1/2025

Do not use

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

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 8/1/2025

Ask a doctor before use if you have

deep or pucture wounds, animal bites or serious burns

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/1/2025

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: 8/1/2025

Inactive ingredient

purified water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/1/2025

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: 8/1/2025

Directions

First aid antiseptic:

  • clean the affected area
  • spray a small amount of the 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 equal amount of water

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

  • use up to 4 times daily after meals and at bedtime

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

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

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Hydrogen Peroxide - FDA Drug Approval Details