Active Ingredient
Hydrogen peroxide(stabilized) 3%
Hydrogen Peroxide Solution
FDA Label NDC 53942-871
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Demoulas Super Markets, Inc for the product Hydrogen Peroxide (NDC 53942-871). 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 you have, 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
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
•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 Information
keep tightly closed and at controlled room temperature. Do not shake bottle. Hold away from face when opening
Inactive Ingredient
purified water
Other
DISTRIBUTED BY DEMOULAS SUPER MARKETS, INC.
875 East Street
Tewksbury, MA 01876
Package Label.Principal Display Panel
Market Basket
MORE FOR YOUR DOLLAR
HYDROGEN PEROXIDE TOPICAL SOLUTION USP
FIRST AID ANTISEPTIC
ORAL DEBRIDING AGENT
Square bottle uses less plastic than a similarly sized round bottle
Recyclable (if available in your area)
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
16 FL OZ (1 PT) (473 mL)
Image Of Principal Display Panel (Mm1)
871.001/871AA
* Please review the disclaimer below.
