Hydrogen Peroxide Solution
FDA Label NDC 0404-0001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Henry Schein Inc. for the product Hydrogen Peroxide (NDC 0404-0001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Hydrogen Peroxide (stabilized) 3%

Purpose

First Aid Antiseptic/Oral Debriding Agent

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

Warnings

For external use only

Otc - Do Not Use

Do not use

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

Otc - Ask Doctor

Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.

Otc - Stop Use

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

Otc - 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 (1-800-222-1222).

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

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

Principal Display Panel (3.79 L Bottle Label)

Principal Display Panel (3.79 L Bottle Label)

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