3% Hydrogen Peroxide Solution
FDA Label NDC 52000-433

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product 3% Hydrogen Peroxide (NDC 52000-433). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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, mucus, or other secretions associated with an occasional sore mouth

Warnings

For external use only.

When using this product • do not get into eyes • do not apply over large areas of the body • do not use longer than one week unless directed by a 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 (1-800-222-1222) 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

For use as an oral debriding agent (oral rinse)
• adults and children over 2 years of age:
  • mix with an equal amount of water
  • swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow
  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
children under 12 years 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 store at controlled room temperature.
• do not shake the bottle. Hold away from face when opening.

Inactive Ingredient

purified Water

Packaging

Hydrogenperoxide (52000433 4)

Hydrogenperoxide (52000433 4)

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