Hydrogen Peroxide

Hydrogen Peroxide
SPL v11
SPL
SPL Set ID d97671f0-b182-4dab-87d2-cf9919509da5
Route
TOPICAL
Published
Effective Date 2022-12-20
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 2014-06-01

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 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 (1-800-222-1222).

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 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
Warnings

For external use only

Directions
First Aid Antiseptic
  • clean the affected area
  • apply a small amount of product on the 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 age & 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

Questions Or Comments?

1-800-472-4346

Principal Display Panel 3.79 L Bottle Label

Item # 112-7070

NDC 0404-0001-01

HENRY SCHEIN ®

3 % Hydrogen

Peroxide Solution

U.S.P. FIRST AID ANTISEPTIC

Tamper evident cap for your protection. If ring-band

is detached from cap or missing do not use.

Distributed by (in US Only):

HENRY SCHEIN INC.

135 Duryea Road

Melville, NY 11747 USA

Rev. Date 2018/06 Made in the USA

128 FL OZ (1 Gal.) • 3.79 L


Structured Label Content

Uses
  • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
  • aids in 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 (1-800-222-1222).

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 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
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 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 age & 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

Questions Or Comments? (Questions or Comments?)

1-800-472-4346

Principal Display Panel 3.79 L Bottle Label (PRINCIPAL DISPLAY PANEL - 3.79 L Bottle Label)

Item # 112-7070

NDC 0404-0001-01

HENRY SCHEIN ®

3 % Hydrogen

Peroxide Solution

U.S.P. FIRST AID ANTISEPTIC

Tamper evident cap for your protection. If ring-band

is detached from cap or missing do not use.

Distributed by (in US Only):

HENRY SCHEIN INC.

135 Duryea Road

Melville, NY 11747 USA

Rev. Date 2018/06 Made in the USA

128 FL OZ (1 Gal.) • 3.79 L


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)