Hydrogen Peroxide 3%
Hydrogen Peroxide 3% v/v First aid anitseptic debriding agent
Hydrogen Peroxide
FDA Label NDC 80668-313
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ubq Industries, Llc for the product Hydrogen Peroxide (NDC 80668-313). 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 hydrogen peroxide 3%, first aid antiseptic debriding agent, indications and usage section, warnings section, 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
First Aid Antiseptic Debriding Agent
First aid antiseptic debriding agent
Indications And Usage Section
• 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 Section
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 gets worse
• Sore mouth symptoms do not improve in 7 days
• Irritation, pain, or redness persists or worsens
Keep Out Of Reach Of Children.
If swallowed, 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 fry 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
• Mix with equal amount of water
• Swish around in the mouth over affect 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
Other Information
• Keep tightly closed and in a dark place at room temperature
• Do not shake bottle. Hold away from face when opening
Inactive Ingredients
Purified water
Package Label - Principal Display Panel
18927 ml NDC 80668-313-01
18927ml (hydrogen)
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