Pharmacys Prescription Hydrogen Peroxide

Manufacturer
American Consumer Products Corp
Effective date
2020-09-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:12

Label at a glance#

ProductPharmacys Prescription Hydrogen Peroxide
Active ingredientHYDROGEN PEROXIDE
Label structure13 sections

Indications and 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.

Dosage and administration

Directions. First aid antiseptic : • clean the affected area • apply small amount of product on the affected area 1 to 3 times a day • may be covered with sterile bandage • if bandaged, let dry first. Oral debriding agent: adults, children over 2 years of age: • mix with 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 mea...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Hydrogen peroxide (stabilized) 3%

Purpose

OTC - PURPOSE SECTION

Purpose

First aid antiseptic. Oral debriding agent.

Uses

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 associated with occasional sore mouth.

Warnings

WARNINGS SECTION

Warnings For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use in the eyes, or apply over large ares of the body longer than 1 week.

Ask a doctor

OTC - ASK DOCTOR SECTION

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

Stop use

OTC - STOP USE SECTION

Stop use and ask 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions.

First aid antiseptic: • clean the affected area • apply small amount of product on the affected area 1 to 3 times a day • may be covered with sterile bandage • if bandaged, let dry first.

Oral debriding agent: adults, children over 2 years of age: • mix with 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

SPL UNCLASSIFIED SECTION

Other information keep tightly closed and at controlled room temperature. Do not shake bottle. Hold away from face when opening.

Inactive ingredient

INACTIVE INGREDIENT SECTION

Inactive ingredient: purified water.

Distributed by

SPL UNCLASSIFIED SECTION

Distributed By:

American Consumer Products Corp.

Vernon, CA 90058

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pharmacys Prescription Hydrogen PeroxidePharmacys Prescription Hydrogen Peroxide

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN1
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD1
91349hydrogen peroxide 3 % Topical SolutionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130757437916038GTIN-13: 0757437916038
EAN-13: 0757437916038
GTIN-12: 757437916038
UPC-A: 757437916038
GTIN storage (14 digits): 00757437916038
72197-038-16_Pharmacys_Prescription_Hydrogen_Peroxide.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72197-038-162022-01-28C16284748780-1d6a99b39-c8f8-a426-e053-dadaa90af4c2Pharmacys Prescription Hydrogen Peroxide 3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72197-038-16Pharmacys Prescription Hydrogen Peroxide473.17 mL in 1 BOTTLE, PLASTICLIQUID473.171

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72197-038PHARMACYS PRESCRIPTION HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) LIQUID [AMERICAN CONSUMER PRODUCTS CORP]1Legacy NDC, 1 package rows20200914_af1282ff-905a-3fd8-e053-2a95a90ac41b.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72197-03872197-038-16

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
HYDROGEN PEROXIDEBBX060AN9VACTIB
WATER059QF0KO0RIACT

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
af1282ff-905b-3fd8-e053-2a95a90ac41baf1282ff-905a-3fd8-e053-2a95a90ac41b2020-09-14WarningsExact identifier
spl id: af1282ff-905b-3fd8-e053-2a95a90ac41b
spl set id: af1282ff-905a-3fd8-e053-2a95a90ac41b

Reported adverse events (FAERS/openFDA)#

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