3% Hydrogen Peroxide

3% Hydrogen Peroxide
SPL v1
SPL
SPL Set ID 53573a9c-bddc-49ea-931e-4779a20eb14f
Route
TOPICAL
Published
Effective Date 2025-12-15
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 2025-12-08

Description

Hydrogen peroxide (stabilized) 3%

Purpose

First aid antiseptic / oral debriding agent


Medication Information

Purpose

First aid antiseptic / oral debriding agent

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 an occasional sore mouth

Section 42229-5

For the Treatment of Minor Cuts and Abrasions

For Use as a Gargle or Rinse

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

Mfd for and Distributed by:

Universal Distribution Center LLC

330 Applegarth Road, Monroe Township,

NJ 08831

www.universaldc.com

“U” is a Registered Trademark of

Universal Distribution Center, LLC

Made in Turkey

Section 50565-1

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

Warnings

For external use only.

When using this product • do not get into eyes • do not apply over large areas of the body • do not use longer than one week unless directed by a doctor

Ask a doctor before use if you have

• deep or puncture wounds, animal bites, or serious burns

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

Packaging

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

For use as an oral debriding agent (oral rinse)

• adults and children over 2 years of age:

  • 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

Drug Facts

Active Ingredient

Hydrogen peroxide (stabilized) 3%

Other Information

• keep tightly closed and store at controlled room temperature.

• do not shake the bottle. Hold away from face when opening.

Inactive Ingredient

purified Water


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 an occasional sore mouth

Section 42229-5 (42229-5)

For the Treatment of Minor Cuts and Abrasions

For Use as a Gargle or Rinse

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

Mfd for and Distributed by:

Universal Distribution Center LLC

330 Applegarth Road, Monroe Township,

NJ 08831

www.universaldc.com

“U” is a Registered Trademark of

Universal Distribution Center, LLC

Made in Turkey

Section 50565-1 (50565-1)

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

Purpose

First aid antiseptic / oral debriding agent

Warnings

For external use only.

When using this product • do not get into eyes • do not apply over large areas of the body • do not use longer than one week unless directed by a doctor

Ask a doctor before use if you have

• deep or puncture wounds, animal bites, or serious burns

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

Packaging

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

For use as an oral debriding agent (oral rinse)

• adults and children over 2 years of age:

  • 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

Drug Facts

Active Ingredient (Active ingredient)

Hydrogen peroxide (stabilized) 3%

Other Information (Other information)

• keep tightly closed and store at controlled room temperature.

• do not shake the bottle. Hold away from face when opening.

Inactive Ingredient (Inactive ingredient)

purified Water


Advanced Ingredient Data


Raw Label Data

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