FDA.reportPublic FDA data

White Labs

Manufacturer
BIOSTECH CO., LTD.
Effective date
2018-04-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:55:08

Label at a glance#

ProductWhite Labs
Active ingredientHydrogen Peroxide
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide 2.80%

OTC - PURPOSE SECTION

Oral Debriding

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Use up to 2 times daily after meals and at bedtime

children under 13 years of age Do not use

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

INACTIVE INGREDIENT SECTION

Distilated water, Polyvinyl alcohol, Titanium dioxide, Poloxamer 407, Glycerine, PEG400, Ethanol, PVP K29/32(Povidone), PVP K90(Povidone), Aerosil 200, Flavor(Applemint HF62184), Citric Acid, Sodium Citric Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70812-001-022020-01-31C16284748780-19d75b9cf-fa07-f424-e053-dadaa90a57ceDrug Facts
70812-001-042020-01-31C16284748780-19d75b9cf-fa07-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70812-001-01White Labs15 g in 1 TUBELIQUID154
70812-001-02White Labs1 in 1 CARTONLIQUID14
70812-001-03White Labs20 g in 1 PACKAGELIQUID204
70812-001-04White Labs1 in 1 CARTONLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70812-001WHITE LABS (HYDROGEN PEROXIDE) LIQUID [BIOSTECH CO., LTD.]4Legacy NDC, 4 package rows20180402_b8dfa7fa-6601-4eb3-9473-02128e1557c1.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70812-00170812-001-01, 70812-001-02, 70812-001-03, 70812-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
Hydrogen PeroxideBBX060AN9VACTIB
WATER059QF0KO0RIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLOXAMER 407TUF2IVW3M2IACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
ALCOHOL3K9958V90MIACT
POVIDONE K29/32390RMW2PEQIACT
POVIDONE K90RDH86HJV5ZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MENTHA SUAVEOLENS WHOLEG0O5N5EA8XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT

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
838c3b30-37c8-4e66-a48c-28d3d2ea7899b8dfa7fa-6601-4eb3-9473-02128e1557c12018-04-01WarningsExact identifier
spl id: 838c3b30-37c8-4e66-a48c-28d3d2ea7899
spl set id: b8dfa7fa-6601-4eb3-9473-02128e1557c1

Reported adverse events (FAERS/openFDA)#

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