Hydrogen Peroxide
Rexall 871.001/871AA 3% Hydrogen Peroxide
3c823b47-2ab7-4002-9b6f-abf0a3176b44
HUMAN OTC DRUG LABEL
Aug 12, 2025
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
Product Classification
Product Specifications
INGREDIENTS (2)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
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, mucous or other secretions associated with occasional sore mouth
ADVERSE REACTIONS SECTION
adverse reactions
Distributed by: Old East Main Co.
100 MISSION RIDGE GOODLETTSVILLE, TN 37072
Pat. D675, 101
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Hydrogen peroxide (stabilized) 3%
Purpose
First aid antiseptic
Oral debriding agent
WARNINGS SECTION
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
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
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