Hydrogen Peroxide

Manufacturer
Pioneer Associates | Anicare Pharmaceuticals Pvt. Ltd
Effective date
2012-08-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:32:51

Label at a glance#

ProductHydrogen Peroxide
Active ingredientHYDROGEN PEROXIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (by volume)

Hydrogen Peroxide 3%

OTC - PURPOSE SECTION

Purpose

first aid antiseptic/oral debriding agent

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 SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • in the eyes or apply over large areas of the body
  • longer than one week
  • on deep or puncture wounds, animal bites or on serious burns

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • the condition persists or gets worse
  • swelling, rash or fever develops
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children.

If swallowed, seek professional assistance or contact a Poison Control Center immediately.

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 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

SPL UNCLASSIFIED SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredient

Water

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

CAVALIER HYDROGEN PEROXIDE SOLUTION

FIRST AID ANTISEPTIC/ORAL DEBRIDING AGENT

16 FL.OZ (473 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hydrogen-peroxidehydrogen-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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53033-003-01Hydrogen Peroxide119 mL in 1 BOTTLE, PLASTICSOLUTION1191
53033-003-02Hydrogen Peroxide178 mL in 1 BOTTLE, PLASTICSOLUTION1781
53033-003-03Hydrogen Peroxide237 mL in 1 BOTTLE, PLASTICSOLUTION2371
53033-003-04Hydrogen Peroxide295 mL in 1 BOTTLE, PLASTICSOLUTION2951
53033-003-05Hydrogen Peroxide354 mL in 1 BOTTLE, PLASTICSOLUTION3541
53033-003-06Hydrogen Peroxide414 mL in 1 BOTTLE, PLASTICSOLUTION4141
53033-003-07Hydrogen Peroxide473 mL in 1 BOTTLE, PLASTICSOLUTION4731
53033-003-08Hydrogen Peroxide100 mL in 1 BOTTLE, PLASTICSOLUTION1001
53033-003-09Hydrogen Peroxide200 mL in 1 BOTTLE, PLASTICSOLUTION2001
53033-003-10Hydrogen Peroxide250 mL in 1 BOTTLE, PLASTICSOLUTION2501
53033-003-11Hydrogen Peroxide266 mL in 1 BOTTLE, PLASTICSOLUTION2661

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53033-003HYDROGEN PEROXIDE SOLUTION [PIONEER ASSOCIATES]1Legacy NDC, 11 package rows20120827_3faa36a2-3d15-42a2-a03e-a76ef4e5d506.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROGEN PEROXIDEACTIVE INGREDIENTBBX060AN9V1
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9V1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

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

NDC Codes#

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 PEROXIDEBBX060AN9VACTIM
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
001adbf8-50c8-44e1-9c78-4993c42c27b13faa36a2-3d15-42a2-a03e-a76ef4e5d5062012-08-24WarningsExact identifier
spl id: 001adbf8-50c8-44e1-9c78-4993c42c27b1
spl set id: 3faa36a2-3d15-42a2-a03e-a76ef4e5d506

Reported adverse events (FAERS/openFDA)#

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