FDA.reportPublic FDA data

Humco Hydrogen Peroxide

Manufacturer
Humco Holding Group, Inc.
Effective date
2020-06-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:18:28

Label at a glance#

ProductHumco Hydrogen Peroxide
Active ingredientHYDROGEN PEROXIDE
Label structure15 sections

Indications and uses

As an antiseptic to help prevent infection in minor cuts, scrapes, burns.

Dosage and administration

For antiseptic use: Clean the affected area, apply a small amount on the area 1 to 3 times daily. For oral rinse use: Adults and children 2 years and older mix with an equal amount of water and swish around and over the affected area then spit out. Use up to 4 times daily or as directed by a dentist or a doctor. Children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide 3%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

As an antiseptic to help prevent infection in minor cuts, scrapes, burns.

SPL UNCLASSIFIED SECTION

As an oral rinse for temporary use in cleaning of minor wounds or irritation/inflammation to the mouth and gums resulting from minor dental procedures, orthodontic appliances or accidental injury.

Warnings

WARNINGS SECTION

For external use except when used as an oral rinse.

Do not use in the eyes.

Do not apply over large areas of the body.

Do not use longer than 1 week unless directed by a dentist or doctor.

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites, serious burns.

Stop use consult a dentist or doctor if:

OTC - STOP USE SECTION

condition persists or gets worse, sore mouth symptoms do not improve in 7 days, irritation, pain, redness or fever develop.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of acciedntal ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

For antiseptic use: Clean the affected area, apply a small amount on the area 1 to 3 times daily.

For oral rinse use: Adults and children 2 years and older mix with an equal amount of water and swish around and over the affected area then spit out. Use up to 4 times daily or as directed by a dentist or a doctor.

Children under 2 years of age: consult a doctor.

Other information

OTHER SAFETY INFORMATION

Keep tightly closed and at controlled room temperature 15-30C (59-86F).

Do not shake.

Inactive ingredient

INACTIVE INGREDIENT SECTION

Purified water

Good Neighbor Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GNPGNP

Sunmark Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SMH2O2.jpgSMH2O2.jpgSunmarkSunmark

Health Mart Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HMH2O2.jpgHMH2O2.jpgHMHM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN3
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD3
91349hydrogen peroxide 3 % Topical SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0395-9116-162022-07-29C16284748780-1e4f33bdf-9bb8-d8a0-e053-dadaa90a6e4ePrivate Label Hydrogen Peroxide 3%, USP
0395-9116-942022-07-29C16284748780-1e4f33bdf-9bb8-d8a0-e053-dadaa90a6e4ePrivate Label Hydrogen Peroxide 3%, USP
0395-9116-982022-07-29C16284748780-1e4f33bdf-9bb8-d8a0-e053-dadaa90a6e4ePrivate Label Hydrogen Peroxide 3%, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-9116-16Humco Hydrogen Peroxide473 mL in 1 BOTTLE, PLASTICLIQUID4733
0395-9116-94Humco Hydrogen Peroxide113 mL in 1 BOTTLE, PLASTICLIQUID1133
0395-9116-98Humco Hydrogen Peroxide237 mL in 1 BOTTLELIQUID2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9116HUMCO HYDROGEN PEROXIDE (HYDROGEN PEROXIDE 3%) LIQUID [HUMCO HOLDING GROUP, INC.]3Legacy NDC, 3 package rows20200622_6062c42c-7a43-ecbf-e053-2a91aa0a55f8.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0395-91160395-9116-16, 0395-9116-94, 0395-9116-98

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
NameUNIIKind
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a883f0c0-7c23-1de7-e053-2995a90ac89b6062c42c-7a43-ecbf-e053-2a91aa0a55f82020-06-20WarningsExact identifier
spl id: a883f0c0-7c23-1de7-e053-2995a90ac89b
spl set id: 6062c42c-7a43-ecbf-e053-2a91aa0a55f8

Reported adverse events (FAERS/openFDA)#

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