Hydrogen Peroxide

Manufacturer: NDC, Inc.
Effective date: 2026-01-08
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: monthly-update
Hydrated at: 2026-06-03 17:51:43

Label at a glance#

ProductHydrogen Peroxide

Active ingredientHYDROGEN PEROXIDE

Label structure9 sections

Indications and uses

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

Dosage and administration

First Aid Antiseptic clean the affected area apply a small amount of product on the 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 & 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 ...

Storage and handling

Keep tightly closed in a cool dark place Do not shake bottle Hold away from face when opening

Contacts and useful links#

Websitewww.proadvantagebyndc.com

www.ProAdvantagebyNDC.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide (stabilized) 3%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic/Oral Debriding Agent

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you havedeep or puncture wounds, animal bites or serious burns.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

First Aid Antiseptic

clean the affected area
apply a small amount of product on the 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 & 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

Other Information

STORAGE AND HANDLING SECTION

Keep tightly closed in a cool dark place
Do not shake bottle
Hold away from face when opening

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Purified Water

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REF: P903016
NDC 43128-001-16

Hydrogen
Peroxide
3% USP

Tamper evident cap for your protection. If ring-band is
detached from cap or missing do not use.

16oz. ( 473mL )

Made in USA for:
NDC, Inc., 407 New Sanford Rd.
La Vergne, TN 37086
www.ProAdvantagebyNDC.com

Pro
ADVANTAGE ^®
by NDC

Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
91349	hydrogen peroxide 3 % Topical Solution	PSN	12
91349	hydrogen peroxide 30 MG/ML Topical Solution	SCD	12
91349	hydrogen peroxide 3 % Topical Solution	SY	12

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43128-001-08	Hydrogen Peroxide	237 mL in 1 BOTTLE, PLASTIC	SOLUTION	237		12
43128-001-16	Hydrogen Peroxide	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Hydrogen Peroxide	ACTIVE INGREDIENT	BBX060AN9V	1
Hydrogen Peroxide	ACTIVE MOIETY	BBX060AN9V	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Hydrogen Peroxide
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43128-001	43128-001-16, 43128-001-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
HYDROGEN PEROXIDE	BBX060AN9V	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
11	2024-11-14	full-release	2026-06-01 00:37:18

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrogen Peroxide	HYDROGEN PEROXIDE	NDC, Inc.	23f7a9dc-5a6b-4f17-bf76-3864c4881525	2026-01-08	Warnings	Exact identifier ndc (package): 43128-001-16 ndc (package): 43128-001-08 ndc (product): 43128-001 ndc11 (package): 43128000108 ndc11 (package): 43128000116 spl id: 47e67184-d1bf-03e9-e063-6394a90ac4f6 spl set id: 23f7a9dc-5a6b-4f17-bf76-3864c4881525

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.