Hydrogen Peroxide Solution
FDA Label NDC 55910-871

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Old East Main Co. for the product Hydrogen Peroxide (NDC 55910-871). 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 active ingredient, purpose, uses, warnings, do not use, as a doctor before use if you have, stop use and ask a doctor if, 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

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

Warnings

For external use only

Do Not Use

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

As 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

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 affected area 1 to 3 times a day
•may be covered with a sterile bandage
•if bandaged, let dry first

Oral debriding agent 9oral 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.

Inactive Ingredient

purified water

Adverse Reactions

Distributed by

Old East Main

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

871.000/871AA

Principal Display Panel

Rexall
Hydrogen Peroxide Topical Solution USP

3% H202

  • For treatment of minor cuts and abrasions
  • First Aid Antiseptic

    • 10 FL OZ (295 mL)

    Image Description (Mm3)

    Image Description (Mm3)

    Hydrogen Peroxide Topical Solution USP

    • First aid antiseptic
    • Oral debriding agent

      • For treatment of minor cuts and abrasions

      Do not use if printed seal under cap is broken or missing

      100% satisfaction guaranteed (888)309-9030

      16 FL OZ (1 PT) 473 mL

      Image Description (Mm01)

      Image Description (Mm01)

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