FDA Label for Hydrogen Peroxide

View Indications, Usage & Precautions

Hydrogen Peroxide Product Label

The following document was submitted to the FDA by the labeler of this product Demoulas Super Markets, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

•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)

871.001/871AA


* Please review the disclaimer below.