Hydrogen Peroxide

Hydrogen Peroxide
SPL v12
SPL
SPL Set ID f854ff4f-1327-4e2a-9389-591b01ba3ee2
Route
TOPICAL
Published
Effective Date 2023-08-14
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 2023-08-14

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, mucous, or other secretions associated with occasional sore mouth

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50569-3

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns

Warnings

For external use only

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 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 the eyes or apply over large areas of the body

longer than 1 week

Active Ingredient

Hydrogen Peroxide (stabilized) 3%

Other Information

Keep tightly closed in a cool dark place. Do not shake bottle. Hold away from face when opening.

Inactive Ingredient

purified water

Principal Display Panel – 473 Ml Bottle Label

HCS

NDC 83506-001-16

Solution of

Hydrogen Peroxide

3% USP 10 Volume

FIRST AID ANTISEPTIC

ORAL DEBRIDING AGENT

  • For treatment of minor

    cuts, scrapes, and burns
  • For use as a gargle or rinse
  • For external use only

SEALED FOR YOUR PROTECTION

IF THE SEAL IS BROKEN OR MISSING DO NOT USE

16 FL OZ (1 PT) 473 mL


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, mucous, or other secretions associated with occasional sore mouth

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns

Purpose

First aid antiseptic/Oral debriding agent

Warnings

For external use only

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 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 the eyes or apply over large areas of the body

longer than 1 week

Active Ingredient (Active ingredient)

Hydrogen Peroxide (stabilized) 3%

Other Information (Other information)

Keep tightly closed in a cool dark place. Do not shake bottle. Hold away from face when opening.

Inactive Ingredient (Inactive ingredient)

purified water

Principal Display Panel – 473 Ml Bottle Label (Principal Display Panel – 473 mL Bottle Label)

HCS

NDC 83506-001-16

Solution of

Hydrogen Peroxide

3% USP 10 Volume

FIRST AID ANTISEPTIC

ORAL DEBRIDING AGENT

  • For treatment of minor

    cuts, scrapes, and burns
  • For use as a gargle or rinse
  • For external use only

SEALED FOR YOUR PROTECTION

IF THE SEAL IS BROKEN OR MISSING DO NOT USE

16 FL OZ (1 PT) 473 mL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)