Assured 871.001/871aa

Assured 871.001/871aa
SPL v15
SPL
SPL Set ID ce4e301b-af91-4fa0-a64c-4b235a5ff07d
Route
TOPICAL
Published
Effective Date 2025-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (30 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-05-12 Until 2022-03-20

Description

Hydrogen peroxide (stablized) 3%

Purpose

First Aid Antiseptic Oral debriding agent

Adverse Reactions

DISTRIBUTED BY Greenbrier International, Inc 500 Volvo Parkway Chesapeake, VA 23320 Pat. D675, 101


Medication Information

Purpose

First Aid Antiseptic

Oral debriding agent

Adverse Reactions

DISTRIBUTED BY

Greenbrier International, Inc

500 Volvo Parkway

Chesapeake, VA 23320

Pat. D675, 101

Description

Hydrogen peroxide (stablized) 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 assoicated with occasional sore mouth.
Warnings

For external use only

Directions

F irst 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 ago or 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 the body
  • longer than 1 week
Active Ingredient

Hydrogen peroxide (stablized) 3%

Other Information

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

Inactive Ingredient

purified water

Principal Display Panel

Do not use if printed seal under cap is broken or missing

ASSURED™

Hydrogen

Peroxide

TOPICAL SOLUTION USP

FIRST AID ANTISEPTIC

ORAL DEBRIDING AGENT

Square bottle uses less plastic than a similarly sized round bottle

Recyclable (if available in your area)

32 FL OZ (1 QT) 946 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 assoicated with occasional sore mouth.
Purpose

First Aid Antiseptic

Oral debriding agent

Warnings

For external use only

Directions

F irst 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 ago or 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 the body
  • longer than 1 week
Active Ingredient (Active ingredient)

Hydrogen peroxide (stablized) 3%

Adverse Reactions (Adverse reactions)

DISTRIBUTED BY

Greenbrier International, Inc

500 Volvo Parkway

Chesapeake, VA 23320

Pat. D675, 101

Other Information (Other information)

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

Inactive Ingredient (Inactive ingredient)

purified water

Principal Display Panel (Principal display panel)

Do not use if printed seal under cap is broken or missing

ASSURED™

Hydrogen

Peroxide

TOPICAL SOLUTION USP

FIRST AID ANTISEPTIC

ORAL DEBRIDING AGENT

Square bottle uses less plastic than a similarly sized round bottle

Recyclable (if available in your area)

32 FL OZ (1 QT) 946 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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