Hydrogen Peroxide
FDA Label NDC 53175-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dyad Medical Sourcing, Llc for the product Hydrogen Peroxide (NDC 53175-001). 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, otc - do not use, otc - ask doctor, stop use and ask a doctor if, otc - keep out of reach of children, 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 the removal of phlegm, mucous, or other secretions associated with occasional sore mouth

Otc - Do Not Use

For external use only

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 or puncture wounds, animal bites or serious burns

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.

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 in a cool dark place. Do not shake bottle. Hold away from face when opening.

Inactive Ingredient

purified water

Principal Display Panel - 473 Ml Bottle Label

HCS

NDC 53175-001-16

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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

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Principal Display Panel (473 mL Bottle Label)

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