3% Hydrogen Peroxide Solution
FDA Label NDC 52000-433
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product 3% Hydrogen Peroxide (NDC 52000-433). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Hydrogen peroxide (stabilized) 3%
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 an occasional sore mouth
Warnings
For external use only.
When using this product • do not get into eyes • do not apply over large areas of the body • do not use longer than one week unless directed by a doctor
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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
For use as an oral debriding agent (oral rinse)
• adults and children over 2 years of age:
• mix with an 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 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 dentist or doctor
Other Information
• keep tightly closed and store at controlled room temperature.
• do not shake the bottle. Hold away from face when opening.
Inactive Ingredient
purified Water
Packaging
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