hydrogen peroxide

hydrogen peroxide
SPL v14
SPL
SPL Set ID fefaf5ff-e5f4-40d9-a415-a54fb5592ae1
Route
topical
Published
Effective Date 2024-09-15
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 2013-10-09 Until 2021-09-02

Purpose

First Aid Antiseptic/Oral Debriding Agent

Description

Drug Facts


Medication Information

Warnings
  • For external use only
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
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
Other Information

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

Description

Drug Facts

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 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 or 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
Section 51945-4

68599-2301-2

McKesson

Hydrogen Peroxide 3%

118mL

Active Ingredient

Hydrogen Peroxide (stabilized) 3%

Inactive Ingredient

purified water

Principal Display Panel 473 Ml Bottle Label

NDC 68599-2301-6

McKESSON

Hydrogen



Peroxide 3%

TOPICAL SOLUTION USP

FIRST AID ANTISEPTIC

ORAL DEBRIDING AGENT

For treatment of minor cuts and abrasions.

For use as a gargle or rinse. Tamper evident cap

for your protection. If ring-band is detached from

cap or missing, do not use.

16FL OZ (1 pt)

(473 mL)

MFR # 23-D0012

Distributed By McKesson Medical-Surgical Inc.



Richmond, VA 23233



LU-5750-1112 1-07-D0012R10



Made in USA

Principal Display Panel 473 Ml Drug Facts Panel

Drug Facts


Structured Label Content

Warnings
  • For external use only
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
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
Other Information

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

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 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 or 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
Section 51945-4 (51945-4)

68599-2301-2

McKesson

Hydrogen Peroxide 3%

118mL

Active Ingredient

Hydrogen Peroxide (stabilized) 3%

Inactive Ingredient

purified water

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

NDC 68599-2301-6

McKESSON

Hydrogen



Peroxide 3%

TOPICAL SOLUTION USP

FIRST AID ANTISEPTIC

ORAL DEBRIDING AGENT

For treatment of minor cuts and abrasions.

For use as a gargle or rinse. Tamper evident cap

for your protection. If ring-band is detached from

cap or missing, do not use.

16FL OZ (1 pt)

(473 mL)

MFR # 23-D0012

Distributed By McKesson Medical-Surgical Inc.



Richmond, VA 23233



LU-5750-1112 1-07-D0012R10



Made in USA

Principal Display Panel 473 Ml Drug Facts Panel (PRINCIPAL DISPLAY PANEL - 473 mL Drug facts panel)

Drug Facts


Advanced Ingredient Data


Raw Label Data

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