Active Ingredient
Active Ingredient
Hydrogen Peroxide 3%
Hydrogen Peroxide
FDA Label NDC 83123-0012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Brosant Group Llc for the product Hydrogen Peroxide (NDC 83123-0012). 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, 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
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 puncture wounds, animal bites or serious burns
Stop Use And Ask A Doctor If
-swelling, rash, or fever develops
-the condition persists or get worse
-sore mouth symptoms do not improve in 7 days
-irritation, pain, or redness persists or worsen
Keep Out Of Reach Of Children
In case of ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Directions
For use as a first aid antiseptic
-clean affected area
-if bandaged, let dry first
-apply small amount of product on affected area 1-3 times a day
-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 and 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 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 od this product
children under 2 years of age: consult a doctor or dentist
Other Information
-keep tightly closed and in a dark place at room temperature
-do not shake botlle. Hold away from face when opening
Inactive Ingredient
purified water
Package Label.Principal Display Panel
bioliving
3% hydrogen peroxide
topical solution USP
Tamper evident: do not use if seal under cap is broken or missing
32 FL OZ (1 QT) 946 mL
Principal Display (Ndchp)
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