Hydrogen Peroxide
Assured 871.001/871AA 3% Hydrogen Peroxide
ce4e301b-af91-4fa0-a64c-4b235a5ff07d
HUMAN OTC DRUG LABEL
Jul 31, 2025
Greenbrier International, Inc
DUNS: 610322518
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
Product Classification
Product Specifications
INGREDIENTS (2)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal display panel
Do not use if printed seal under cap is broken or missing
ASSURED™
Hydrogen
Peroxide
TOPICAL SOLUTION USP
FIRST AID ANTISEPTIC
ORAL DEBRIDING AGENT
Square bottle uses less plastic than a similarly sized round bottle
Recyclable (if available in your area)
32 FL OZ (1 QT) 946 mL
INDICATIONS & USAGE SECTION
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 assoicated with occasional sore mouth.
ADVERSE REACTIONS SECTION
Adverse reactions
DISTRIBUTED BY
Greenbrier International, Inc
500 Volvo Parkway
Chesapeake, VA 23320
Pat. D675, 101
OTC - STOP USE SECTION
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 - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
WARNINGS SECTION
Warnings
For external use only
OTC - DO NOT USE SECTION
Do not use
- in the eyes or apply over large areas of the the body
- longer than 1 week
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
deep or puncture wounds, animal bites or serious burns
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Hydrogen peroxide (stablized) 3%
OTC - PURPOSE SECTION
Purpose
First Aid Antiseptic
Oral debriding agent
DOSAGE & ADMINISTRATION SECTION
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 ago or 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 of this product
-
children under 2 years of age: consult a dentist or doctor
STORAGE AND HANDLING SECTION
Other information
keep tightly closed and at controlled room temperature. Do not shake bottle. Hold away from face when opening.
INACTIVE INGREDIENT SECTION
Inactive ingredient
purified water