GuruNanda Oxyfusion

Manufacturer
GURUNANDA, LLC
Effective date
2025-11-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:43:17

Label at a glance#

ProductGuruNanda Oxyfusion
Active ingredientHYDROGEN PEROXIDE
Label structure9 sections

Indications and uses

For temporary use in cleansing minor wounds or minor gum inflammation resulting from: minor dental procedures dentures orthodontic appliances accidental injury canker sores other irritations of the mouth and gums Aids in the removal of: phlegm mucus other secretions associated with occasional sore mouth

Dosage and administration

Ready to use, no mixxing needed. Close cap tightly. Adults and children 2 years of age and older: Swish 10 mL around 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 doc...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen peroxide 1.5%

Purpose

OTC - PURPOSE SECTION

Oral debriding agent/oral antiseptic

Uses

INDICATIONS & USAGE SECTION

For temporary use in cleansing minor wounds or minor gum inflammation resulting from:

  • minor dental procedures
  • dentures
  • orthodontic appliances
  • accidental injury
  • canker sores
  • other irritations of the mouth and gums

Aids in the removal of:

  • phlegm
  • mucus
  • other secretions associated with occasional sore mouth

Warnings

WARNINGS SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

this product for more than 7 days unless directed by a dentist or doctor

When using this product

OTC - WHEN USING SECTION

  • do not swallow
  • do not exceed recommended dosage

Stop use and see your dotor if

OTC - STOP USE SECTION

  • 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

if more than used for rinsing is accidently swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

Ready to use, no mixxing needed. Close cap tightly.

Adults and children 2 years of age and older: Swish 10 mL around 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.

Other information

OTHER SAFETY INFORMATION

  • Do not use if printed safety seal on the bottle's neck is broken or missing
  • Recommended storage temperature 59°F-77°F (15°C-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Caprylic/Capric/Lauric Triglyceride, Citric Acid, D-Alpha Tocopherol (Vitamin E), Eucalyptus Oil, Menaquinone-7 (Vitamin K2 MK-7), Menthol, PEG-40 Hydrogenated Castor Oil, Peppermint Oil, Poloxamer 407, Sodium Benzoate, Sorbitol, Stevia Leaf Extract, Thyme Oil, Water, Wintergreen, Oil, Xylitol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

08855.1608855.16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

08855.3308855.33

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
358975hydrogen peroxide 1.5 % MouthwashPSN4
358975hydrogen peroxide 15 MG/ML MouthwashSCD4
358975hydrogen peroxide 1.5 % MouthwashSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810051087789GTIN-13: 0810051087789
EAN-13: 0810051087789
GTIN-12: 810051087789
UPC-A: 810051087789
GTIN storage (14 digits): 00810051087789
08855.16.jpg
BarcodeEAN-130810051088557GTIN-13: 0810051088557
EAN-13: 0810051088557
GTIN-12: 810051088557
UPC-A: 810051088557
GTIN storage (14 digits): 00810051088557
08855.33.jpg
QR code linkQR Codel.ead.me/bb4rmI08855.16.jpg, 08855.33.jpg

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70708-010-16GuruNanda Oxyfusion473 mL in 1 BOTTLEMOUTHWASH4734
70708-010-33GuruNanda Oxyfusion999 mL in 1 BOTTLEMOUTHWASH9994

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70708-01070708-010-16, 70708-010-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-09-03full-release2026-06-01 01:12:33

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
GuruNanda OxyfusionHYDROGEN PEROXIDEGURUNANDA, LLC3be317b9-a5d8-b198-e063-6394a90af9852025-11-11WarningsExact identifier
ndc (package): 70708-010-16
ndc (package): 70708-010-33
ndc (product): 70708-010
ndc11 (package): 70708001016
ndc11 (package): 70708001033
spl id: 43567bbc-b07d-b605-e063-6294a90aad78
spl set id: 3be317b9-a5d8-b198-e063-6394a90af985

Reported adverse events (FAERS/openFDA)#

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