FDA.reportPublic FDA data

maxim SOLUTION OF Hydrogen Peroxide

Manufacturer
Ostl, Inc. | WILSON MEDICINE COMPANY
Effective date
2015-10-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:43:47

Label at a glance#

Productmaxim Hydrogen Peroxide
Active ingredientHydrogen Peroxide
Label structure10 sections

Storage and handling

Other information Keep tightly closed and in a dark place at a controlled room temperature. Do not shake bottle. Hold away from face when opening. DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN OR REMOVED.

Label contents#

Full prescribing information#

Active ingredient (by volume)

OTC - ACTIVE INGREDIENT SECTION

Hydrogen peroxide 3%

Purpose

OTC - PURPOSE SECTION

first aid antiseptic/oral debriding agent

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately. (1-800-222-1222)

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

For external use only.

Do not use • in the eyes or apply over large areas of the body • longer than one week

Ask 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

DOSAGE & ADMINISTRATION SECTION

Directions

first aid antiseptic:

  • clean affected area
  • apply small amount of product on affected area 1-3 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 affected area for atleast 1 minute and then spit out
  • use upto 4 times daily after meals and at bedtime or as directed by a dentist or doctor
  • children under 12 years should be supervised in the use of this product
  • children under 2 years of age; consult a dentist or doctor

INACTIVE INGREDIENT SECTION

Inactive ingredient purified water, Phosphoric acid as a stabilizer

STORAGE AND HANDLING SECTION

Other information Keep tightly closed and in a dark place at a controlled room temperature. Do not shake bottle. Hold away from face when opening.

DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN OR REMOVED.

SPL UNCLASSIFIED SECTION

3% Topical Solution USP

TOPICAL ANTI-INFECTIVE

  • For treatment of minor cuts and abrasions.

Imported by:

OSTL INC. 5805, White Oak Ave Suite # 16065

Encino, CA 91416, USA

www.ostltrade.com

Made in India

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HPLHPL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN2
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD2
91349hydrogen peroxide 3 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69950-005-012023-01-30C16284748780-1f386c649-aa1a-0266-e053-dadaa90a7c1amaxim SOLUTION OF Hydrogen Peroxide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69950-005-01maxim Hydrogen Peroxide473 mL in 1 BOTTLE, PLASTICLIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69950-005MAXIM HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) LIQUID [OSTL, INC.]2Legacy NDC, 1 package rows20151007_e3997c87-a7b7-4742-b35a-3c2b1d89e627.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Hydrogen PeroxideACTIVE INGREDIENTBBX060AN9V2
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9V2
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NN2
WaterINACTIVE INGREDIENT059QF0KO0R2

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
69950-00569950-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Hydrogen PeroxideBBX060AN9VACTIB
Water059QF0KO0RIACT
PHOSPHORIC ACIDE4GA8884NNIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNLOTION / TOPICAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNAEROSOL, FOAM / VAGINALNAExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNSOLUTION / ORAL19 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNOINTMENT / TOPICALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNSOLUTION / TOPICAL0.23 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNSOLUTION / OPHTHALMICADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNLOTION, AUGMENTED / TOPICAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNPASTE, DENTIFRICE / DENTALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNSPONGE / TOPICALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNTABLET, FILM COATED, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNGEL / TOPICALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNCREAM / TOPICAL13 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNTABLET / ORAL0.04 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION / INTRAVENOUS1294 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNTABLET, ORALLY DISINTEGRATING / ORAL4 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNCREAM / VAGINAL0.56 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION, SOLUTION / INTRAVENOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNTABLET, EXTENDED RELEASE / ORAL0.19 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates

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
8e64279b-e16d-40d6-9cdd-bf59aebcce6ee3997c87-a7b7-4742-b35a-3c2b1d89e6272015-10-06WarningsExact identifier
spl id: 8e64279b-e16d-40d6-9cdd-bf59aebcce6e
spl set id: e3997c87-a7b7-4742-b35a-3c2b1d89e627

Reported adverse events (FAERS/openFDA)#

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