Primal Elements Hydrogen Peroxide

Manufacturer
Spa de Soleil | Spa de Soleil, Inc.
Effective date
2020-08-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:15:09

Label at a glance#

ProductPrimal Elements Hydrogen Peroxide 3 Percent
Active ingredientHYDROGEN PEROXIDE
Label structure8 sections

Indications and 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

For use as a first aid antiseptic: clean affected area if bandaged, let dry first apply small amount of product on affected area 1-3 times a day may be covered with a sterile bandage For use as an 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 at least 1 minute and then spit out. Do not swallow. use ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen peroxide 3%

Purpose

OTC - PURPOSE SECTION

first aid antiseptic/oral debriding agent

Uses

INDICATIONS & USAGE SECTION

  • 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

OTC - DO NOT USE SECTION

  • in the eyes or apply over large areas of the body
  • longer than one week

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds, animal bites or serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For use as a first aid antiseptic:

  • clean affected area
  • if bandaged, let dry first
  • apply small amount of product on affected area 1-3 times a day
  • may be covered with a sterile bandage

For use as an 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 at least 1 minute and then spit out. Do not swallow.
  • use up to 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

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water

Princiapl Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primal Elements Hydrogen Peroxide.jpgPrimal Elements Hydrogen Peroxide.jpg

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
68062-229268062-2292-1, 68062-2292-2

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
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB

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
f1c95a60-2b75-e875-e053-2a95a90ac9f4af88f422-bb21-c3fa-e053-2a95a90a26522023-01-08WarningsExact identifier
spl set id: af88f422-bb21-c3fa-e053-2a95a90a2652

Reported adverse events (FAERS/openFDA)#

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