Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 1cd343f3-00aa-42e9-b57d-7b4587341d0e
Route
TOPICAL
Published
Effective Date 2025-07-11
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 2019-02-28

Description

 Hydrogen peroxide 3%

Purpose

 First aid antiseptic/oral debriding agent


Medication Information

Purpose

 First aid antiseptic/oral debriding agent

Description

 Hydrogen peroxide 3%

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

For external use only.

Directions

For use as a first aid antiseptic:

  • clean affected area
  • if bandaged, let dry first
  • apply small amount if 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 it 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 doctor or dentist 
Do Not Use
  • in the eyes or apply over large areas of the body
  • longer than one week
Package Label
LEADER Hydrogen Peroxide 3% USP
Active Ingredient

 Hydrogen peroxide 3%

Other Information
  • keep tightly closed and in a dark place at room temperature
  • do not shake bottle. Hold away from face when opening
Inactive Ingredient

purified water 

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Hydrogen Peroxide

3% USP

First Aid Antiseptic

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN OHIO 43017

www.myleader.com

Stop Use and Ask A Doctor If
  • 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.

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

Ask A Doctor Before Use If You Have
  • deep puncture wounds, animal bites or serious burns

Structured Label Content

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
Purpose

 First aid antiseptic/oral debriding agent

Warnings

For external use only.

Directions

For use as a first aid antiseptic:

  • clean affected area
  • if bandaged, let dry first
  • apply small amount if 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 it 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 doctor or dentist 
Do Not Use (Do not use)
  • in the eyes or apply over large areas of the body
  • longer than one week
Package Label
LEADER Hydrogen Peroxide 3% USP
Active Ingredient (Active ingredient)

 Hydrogen peroxide 3%

Other Information (Other information)
  • 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)

purified water 

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Hydrogen Peroxide

3% USP

First Aid Antiseptic

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN OHIO 43017

www.myleader.com

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep puncture wounds, animal bites or serious burns

Advanced Ingredient Data


Raw Label Data

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