Hydrogen Peroxide
FDA Label NDC 11822-0871

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Hydrogen Peroxide (NDC 11822-0871). 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, use, warnings, do not use, ask a doctor before use if, 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

→ Purpose

→ Use

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredient

→ Other

→ Principal Display Panel

Active Ingredient

Hydrogen peroxide (stabilized) 3%

Purpose

First aid antiseptic
Oral debriding agent

Use

• first aid to help prevent the rise 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 then 1 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

• 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 (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