Leader 871.001/871aa

Leader 871.001/871aa
SPL v26
SPL
SPL Set ID d1418649-9490-4dab-b89c-9de6bb719642
Route
TOPICAL
Published
Effective Date 2026-01-21
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 2019-03-19

Description

Hydrogen peroxide (stabilized) 3%

Purpose

First aid antiseptic


Medication Information

Purpose

First aid antiseptic

Description

Hydrogen peroxide (stabilized) 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

First aid antiseptic:

  • clean the affected area
  • apply a small amount of product on the affected area 1 to 3 times a day
  • may be covered with a sterile bandage
  • if bandaged, 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 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
Do Not Use
  • in eyes or apply over large areas of the body
  • longer than one week
Questions?

1-888-593-0593

Active Ingredient

Hydrogen peroxide (stabilized) 3%

Other Information

keep tightly closed and at controlled room temperature.  Do not shake bottle.  Hold sprayer tip away from face when opening.

Inactive Ingredient

purified water

Principal Display Panel

LEADER ™

NDC 70000-0022-1

Hydrogen Peroxide

Topical Solution USP, 3%

First Aid Antiseptic

Oral Debriding Agent

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

DIST. BY CAH, DUBLIN, OH 43017

www.myleader.com

1-800-200-6313

©2025 Cardinal Health

Pat. D675, 101

CIN 5516075 REV. 11/25

8 FL OZ (236 mL)

Stop Use and Ask A Doctor If
  • 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
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

deep or 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

Warnings

For external use only

Directions

First aid antiseptic:

  • clean the affected area
  • apply a small amount of product on the affected area 1 to 3 times a day
  • may be covered with a sterile bandage
  • if bandaged, 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 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
Do Not Use (Do not use)
  • in eyes or apply over large areas of the body
  • longer than one week
Questions?

1-888-593-0593

Active Ingredient

Hydrogen peroxide (stabilized) 3%

Other Information (Other information)

keep tightly closed and at controlled room temperature.  Do not shake bottle.  Hold sprayer tip away from face when opening.

Inactive Ingredient (Inactive ingredient)

purified water

Principal Display Panel (principal display panel)

LEADER ™

NDC 70000-0022-1

Hydrogen Peroxide

Topical Solution USP, 3%

First Aid Antiseptic

Oral Debriding Agent

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

DIST. BY CAH, DUBLIN, OH 43017

www.myleader.com

1-800-200-6313

©2025 Cardinal Health

Pat. D675, 101

CIN 5516075 REV. 11/25

8 FL OZ (236 mL)

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

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

deep or puncture wounds, animal bites or serious burns


Advanced Ingredient Data


Raw Label Data

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