SPL v1
SPL
SPL Set ID cd3aad13-51bf-404b-9eaf-71bf1dbdd0f1
Route
TOPICAL
Published
Effective Date 2025-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (3 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-15

Description

Hydrogen peroxide 3%

Purpose

First Aid Antiseptic


Medication Information

Purpose

First Aid Antiseptic

Description

Hydrogen peroxide 3%

Uses

First aid to help prevent the risk of infection in

• Minor cuts

• Scrapes

• Burns

• Aids in the removal of phlegm, Mucus, or other secretions associated with occasional sore mouth.

Section 50565-1

Warnings
  • For external use only
  • Do not use
  • in the eyes or apply over large area of the body Longer 1 week
  • Ask doctor before use if you have deep or puncture wounds, animal bites or serious burns.
  • Stop use and ask a doctor if the condition persist or gets worse
  • Sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persist or worsen
  • swelling, rash or Fever develops
  • Keep out of reach of children :If swallowed ,get medical help or contact a Poison Control Center right away .
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 2 year of age : consult a dentist or doctor.

Directions
  • First aid antiseptic
  • Clean the affected area 
  • Apply a small amount of product on the area 1 to 3 times daily
  • May be covered with a sterile bandage
  • If bandage, 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 the affected area for atleast 1 minute and then spit out.
  • Use up to 4 times daily after meals and after bedtime or as direacted by a dentist or doctor
Product Label

Active Ingredient

Hydrogen peroxide 3%

Other Information
  • Keep bottle tightly closed and controlled room temperature.
  • Do not shake bottle. Hold away from face when opening.
Inactive Ingredients

Water


Structured Label Content

Uses

First aid to help prevent the risk of infection in

• Minor cuts

• Scrapes

• Burns

• Aids in the removal of phlegm, Mucus, or other secretions associated with occasional sore mouth.

Section 50565-1 (50565-1)

Purpose

First Aid Antiseptic

Warnings
  • For external use only
  • Do not use
  • in the eyes or apply over large area of the body Longer 1 week
  • Ask doctor before use if you have deep or puncture wounds, animal bites or serious burns.
  • Stop use and ask a doctor if the condition persist or gets worse
  • Sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persist or worsen
  • swelling, rash or Fever develops
  • Keep out of reach of children :If swallowed ,get medical help or contact a Poison Control Center right away .
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 2 year of age : consult a dentist or doctor.

Directions
  • First aid antiseptic
  • Clean the affected area 
  • Apply a small amount of product on the area 1 to 3 times daily
  • May be covered with a sterile bandage
  • If bandage, 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 the affected area for atleast 1 minute and then spit out.
  • Use up to 4 times daily after meals and after bedtime or as direacted by a dentist or doctor
Product Label (Product label)

Active Ingredient

Hydrogen peroxide 3%

Other Information
  • Keep bottle tightly closed and controlled room temperature.
  • Do not shake bottle. Hold away from face when opening.
Inactive Ingredients (Inactive ingredients)

Water


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)