Hydrogen Peroxide

Hydrogen Peroxide
SPL v13
SPL
SPL Set ID 6d1ddf10-8873-4781-9165-bb1c4bbccfc9
Route
TOPICAL
Published
Effective Date 2022-12-14
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 2018-06-27
Description

Drug Facts

Purpose

First Aid Antiseptic/Oral Debriding Agent

Medication Information

Purpose

First Aid Antiseptic/Oral Debriding Agent

Description

Drug Facts

Uses
  • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
  • aids in removal of phlegm, mucous, or other secretions associated with occasional sore mouth
Section 42229-5

Drug Facts

Section 50565-1

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

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 puncture wounds, animal bites or serious burns.

Section 50570-1

Do not use

  • in the eyes or apply over large areas of the body
  • longer than 1 week
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 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 & 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
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 16 Oz

Structured Label Content

Uses
  • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
  • aids in removal of phlegm, mucous, or other secretions associated with occasional sore mouth
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

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 puncture wounds, animal bites or serious burns.

Section 50570-1 (50570-1)

Do not use

  • in the eyes or apply over large areas of the body
  • longer than 1 week
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 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 & 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
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 16 Oz (Principal Display Panel 16 oz)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:25.980102 · Updated: 2026-03-14T23:12:44.067976