Hydrogen Peroxide

Hydrogen Peroxide
SPL v11
SPL
SPL Set ID 1e7c47f2-c4ea-4853-b597-d0e5e002a202
Route
TOPICAL
Published
Effective Date 2022-12-06
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 2012-09-10

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 the 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.

Section 50569-3

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

Section 50570-1

For external use only

Do not use

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

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
Principal Display Panel 473 Ml Bottle Label

HCS

NDC 53175-001-16

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 SEAL IS BROKEN OR MISSING DO NOT USE

Manufactured for:Dyad Medical Sourcing, LLC

2101 Waukegan Road, Suite 208 Bannockburn, IL 60015

1-855-241-1773 • [email protected]

Made in USA #902-HCS0202 Rev. 02

©2020 Dyad Medical Sourcing, LLC www.hcsmed.com

Reorder No. HCS0202

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 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.

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

For external use only

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

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
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

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
Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

HCS

NDC 53175-001-16

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 SEAL IS BROKEN OR MISSING DO NOT USE

Manufactured for:Dyad Medical Sourcing, LLC

2101 Waukegan Road, Suite 208 Bannockburn, IL 60015

1-855-241-1773 • [email protected]

Made in USA #902-HCS0202 Rev. 02

©2020 Dyad Medical Sourcing, LLC www.hcsmed.com

Reorder No. HCS0202

16 FL OZ (1 PT) 473 mL


Advanced Ingredient Data


Raw Label Data

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