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Hydrogen Peroxide by P & L Development, LLC

Medically reviewed on April 24, 2017

Dosage form: liquid
Ingredients: HYDROGEN PEROXIDE 3mL in 100mL
Labeler: P & L Development, LLC
NDC Code: 49580-0014

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Hydrogen peroxide 3%


first aid antiseptic/oral debriding agent



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)

Do not use

in the eyes or apply over large areas of the body • longer than one week
• on deep or puncture wounds, animal bites, or on serious burns.

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 this and all drugs out of the reach of children.

If swallowed, seek professional assistance
or contact a Poison Control Center immediately.


first aid antiseptic:
• clean affected area
• apply small amount of product on affected area
1-3 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 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 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 in a dark place at a controlled room temperature.
Do not shake bottle. Hold away from face when opening.

Inactive ingredient

purified water

principal display panel

hydrogen peroxide U.S.P

first aid antiseptic

tamper evident-do not use if

printed safety seal on cap is broken or missing

hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0014
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
#Item CodePackage Description
1NDC:49580-0014-3946 mL in 1 BOTTLE, PLASTIC
2NDC:49580-0014-4118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35612/04/2013
Labeler - P & L Development, LLC (101896231)

P & L Development, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.