Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 94b47e74-5a07-4b47-884c-aef95ba555f0
Route
TOPICAL
Published
Effective Date 2025-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (2.65 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-05-15

Description

 Hydrogen peroxide 3%

Purpose

First aid antiseptic/oral debriding agent 


Medication Information

Purpose

First aid antiseptic/oral debriding agent 

Description

 Hydrogen peroxide 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 occasional sore mouth
Warnings

For external use only.

Directions

For use as a first aid antiseptic:

  • clean affected area
  • apply small amount of product on affected area 1-3 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 2 years of age and over:
    • 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 doctor or dentist 
Do Not Use
  • in the eyes or apply over large areas of the body
  • longer than one week
Package Label
TOPCARE HEALTH 3% Hydrogen Peroxide
Active Ingredient

 Hydrogen peroxide 3%

Other Information
  • keep tightly closed and in a dark place at room temperature
  • do not shake bottle. Hold away from face when opening.
Inactive Ingredient

purified water 

Questions Or Comments?

Call toll free 1-888-423-0139

Principal Display Panel

3% USP Hydrogen Peroxide

FIRST AID ANTISEPTIC/ORAL DEBRIDING AGENT

  • For treatment of minor cuts, scrapes and burns
  • For use as an antiseptic gargle or rinse

FL OZ (mL)

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

[email protected]

www.topcarebrand.com

Stop Use and Ask A Docotr 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 (1-800-222-1222) right away. 

Ask A Doctor Before Use If You Have
  • deep 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 associated with occasional sore mouth
Purpose

First aid antiseptic/oral debriding agent 

Warnings

For external use only.

Directions

For use as a first aid antiseptic:

  • clean affected area
  • apply small amount of product on affected area 1-3 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 2 years of age and over:
    • 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 doctor or dentist 
Do Not Use (Do not use)
  • in the eyes or apply over large areas of the body
  • longer than one week
Package Label
TOPCARE HEALTH 3% Hydrogen Peroxide
Active Ingredient (Active ingredient)

 Hydrogen peroxide 3%

Other Information (Other information)
  • keep tightly closed and in a dark place at room temperature
  • do not shake bottle. Hold away from face when opening.
Inactive Ingredient (Inactive ingredient)

purified water 

Questions Or Comments? (Questions or comments?)

Call toll free 1-888-423-0139

Principal Display Panel

3% USP Hydrogen Peroxide

FIRST AID ANTISEPTIC/ORAL DEBRIDING AGENT

  • For treatment of minor cuts, scrapes and burns
  • For use as an antiseptic gargle or rinse

FL OZ (mL)

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

[email protected]

www.topcarebrand.com

Stop Use and Ask A Docotr If (Stop use and ask a docotr 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 (1-800-222-1222) right away. 

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep puncture wounds, animal bites or serious burns

Advanced Ingredient Data


Raw Label Data

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