Dop Hydrogen Peroxide 3% Liquid
FDA Label NDC 51048-040
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Omega & Delta Co. Inc. for the product Dop Hydrogen Peroxide 3% (NDC 51048-040). 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, indications & usage, warnings, otc - keep out of reach of children, directions, other safety 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
Indications & Usage
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
Warnings For external use only
Do not use • in the eyes or apply over large areas of the body • do not use longer than 1 week
Ask a doctor before use if you have deep or punctured 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 right away.
Directions
First aid antiseptic:
- clean the affected area
- apply 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.
- 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
Oral debriding agent (oral rinse):
adults and children 2 years of age and over:
Other Safety Information
Other Information Keep thightly closed and a controlled room temperature. Do not
shake bottle. Hold away from face when opening.
Inactive Ingredient
Inactive Ingredient Purified Water.
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