Prevent Hydrogen Peroxide 3 Percent
FDA Label NDC 78835-008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eco-med Pharmaceuticals, Inc. for the product Prevent Hydrogen Peroxide 3 Percent (NDC 78835-008). 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, when using this product:, 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 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 occasional sore mouth.

Warnings:

For external use only.

Do Not Use

in the eyes or apply over large areas of the body longer than one week. Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns. 

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 .

Stop Use And Ask A Doctor If:

Condition persists or gets worse.

If 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.

In case of ingestion, get medical help or contact a Poison Control Center right away.

Directions:

For first aid antiseptic use: Clean affected area, apply small amount of product on affected area 1-3 times a day. May be covered with a sterile bandage, If bandaged, let dry first, For 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 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 in a dark place at room temperature. Do not shake bottle. Hold away from face when opening.

Inactive Ingredient:

Purified water.

Package Labeling:

Label4 (Label4)

Label4 (Label4)

Box4 (Box4)

Box4 (Box4)

* Please review the disclaimer below.