981 Medline Hydrogen Peroxide Solution

Set ID
4593f51a-9bcb-4149-9ce4-4f62183fd3dd
Manufacturer
Medline Industries, LP
Effective date
2026-02-11
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:43:55

Key Label Information

Active Ingredients And Purpose

Active ingredient

Hydrogen peroxide (stabilized) 3%

Purpose

First Aid Antiseptic Oral debriding agent

Uses

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

Warnings

Warnings

For external use only.

Directions And Dosage

Directions

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: adults, children over 2 years of age: mix with an 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, doctor

Other Label Information

Other information

Keep tightly closed. Protect from freezing, avoid excessive heat. Do not shake bottle. Hold away from face when opening.

Inactive ingredients

purified water

Package Label

Products

NDC Codes

Ingredients

NameUNIIKind
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB

Complete SPL Sections

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 the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

Warnings

WARNINGS SECTION

For external use only.

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: adults, children over 2 years of age: mix with an 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, doctor

Other information

STORAGE AND HANDLING SECTION

Keep tightly closed. Protect from freezing, avoid excessive heat. Do not shake bottle. Hold away from face when opening.

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water

Manufacturing Information

SPL UNCLASSIFIED SECTION

www.medline.com Made in US with US and foreign components for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA 1-800-MEDLINE REF: MDS098001Z

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document

Official SPL XML cached by FDA.report ยท DailyMed PDF

XML object
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XML SHA-256
9e2c664ccaf5c3f354921c0c4910432cc4929ddad9f70316a61037285fd91a70
XML bytes
19759

Older Hydrated Versions

VersionEffective dateSourceHydrated
102024-05-29full-release2026-06-01 00:13:08

Legacy File Index

FolderFileDate
otc4a8e4d79-d374-d70e-e063-6394a90a643d.xml2026-02-13
otc41eceae7-ac61-4556-e063-6294a90a88a8.xml2025-10-27
otc53329-981_MDS098001Z_label back.jpg2025-10-27
otc53329-981_MDS098001Z_label front.jpg2025-10-27
otc199e391b-4e37-e7cc-e063-6394a90a3728.xml2024-05-31
otc53329-981_RH17VJO.jpg2022-12-17
otcefe07cd9-7390-d557-e053-2995a90a17a1.xml2022-12-17
otcc7a7ed6f-d1d9-7e14-e053-2a95a90a3060.xml2021-10-07
otc349d0947-0f5f-4ab5-e054-00144ff8d46c.xml2016-06-07
otcc0e8220e-3d9d-437e-9914-7c294988e2ea-01.jpg2016-06-07