Dop Hydrogen Peroxide 3% Liquid
FDA Label NDC 51048-040

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Omega & Delta Co. Inc. for the product Dop Hydrogen Peroxide 3% (NDC 51048-040). 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, indications & usage, warnings, otc - keep out of reach of children, directions, other safety 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

Indications & Usage

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 occasional sore mouth

Warnings

Warnings For external use only

Do not use • in the eyes or apply over large areas of the body • do not use longer than 1 week

Ask a doctor before use if you have deep or punctured 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 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 (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 Safety Information

Other Information  Keep thightly closed and a controlled room temperature.  Do not

shake bottle.  Hold away from face when opening.

Inactive Ingredient

Inactive Ingredient  Purified Water.

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