New Life 3% Hydrogen Peroxide First Aid Antiseptic
FDA Label NDC 49681-016

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by New Life Products, Inc. for the product New Life 3% Hydrogen Peroxide First Aid Antiseptic (NDC 49681-016). 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.

Label Section Quick Index

→ Drug Facts

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients:

→ Packaging

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 occasional sore mouth.

Warnings

• For external use only. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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.

Stop use and ask a doctor if swelling, rash, or fever develops • the condition persists or gets worse • sore mouth symptoms do not improve in 7 days • irritation, pain, redness persists or worsens

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Directions

• For use as a first aid antiseptic:

• clean affected area • apply small amount of product on affected area 1 to 3 times a day • if bandaged, let dry first • may be covered with a sterile bandage

For use as an 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. 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 doctor or dentist.