Hydrogen Peroxide Topical Solution Usp

Hydrogen Peroxide Topical Solution Usp
SPL v3
SPL
SPL Set ID 26bae595-6e76-4946-b98f-1aba2e69250d
Route
TOPICAL
Published
Effective Date 2020-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (0.3 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-15

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 ocassional 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 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 affected area 1 o 3 times a day

√ May be covered with a sterile bandage.

√ If bandaged, let dry first.

Oral debriding agent:

Adults, children over 2 years of age:

√ 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.

√ Children under 12 years of age should be supervised in the use.

√ Children under 2 years of age: consult a dentist, 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 and at controlled room temperature.

√ Do not shake bottle.

√ Hold away form face when opening.

Package Labeling:

Inactive Ingredients:

Purified water

Question Or comments?

Call 956 728-8899

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.

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 ocassional 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 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 affected area 1 o 3 times a day

√ May be covered with a sterile bandage.

√ If bandaged, let dry first.

Oral debriding agent:

Adults, children over 2 years of age:

√ 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.

√ Children under 12 years of age should be supervised in the use.

√ Children under 2 years of age: consult a dentist, doctor.

Do Not Use: (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 and at controlled room temperature.

√ Do not shake bottle.

√ Hold away form face when opening.

Package Labeling:

Inactive Ingredients:

Purified water

Question Or comments? (Question or comments?)

Call 956 728-8899

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.

Advanced Ingredient Data


Raw Label Data

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