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Hydrogen Peroxide by Universal Distribution Center LLC

Medically reviewed on November 27, 2017

Dosage form: liquid
Ingredients: HYDROGEN PEROXIDE 3mL in 100mL
Labeler: Universal Distribution Center LLC
NDC Code: 52000-025

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.

HYDROGEN PEROXIDE LIQUID

Active Ingredient

Hydrogen Peroxide 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 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

  • 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 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 a first aid antiseptic:

  • clean affected area
  • apply small amount of product on the affected area 1-3 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 2 years of age and over:
  • mix with 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 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 Ingredient

Purified Water

PRINCIPAL DISPLAY PANEL

HYDROGEN PEROXIDE LIQUID
FIRST AID ANTISEPTIC/ORAL DEBRIDING AGENT

16 FL.OZ (473 mL)

HYDROGEN PEROXIDE 
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-025
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:52000-025-40100 mL in 1 BOTTLE, PLASTIC
2NDC:52000-025-41119 mL in 1 BOTTLE, PLASTIC
3NDC:52000-025-42178 mL in 1 BOTTLE, PLASTIC
4NDC:52000-025-43200 mL in 1 BOTTLE, PLASTIC
5NDC:52000-025-03237 mL in 1 BOTTLE, PLASTIC
6NDC:52000-025-44250 mL in 1 BOTTLE, PLASTIC
7NDC:52000-025-45266 mL in 1 BOTTLE, PLASTIC
8NDC:52000-025-31295 mL in 1 BOTTLE, PLASTIC
9NDC:52000-025-32354 mL in 1 BOTTLE, PLASTIC
10NDC:52000-025-06414 mL in 1 BOTTLE, PLASTIC
11NDC:52000-025-07473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/25/2015
Labeler - Universal Distribution Center LLC (019180459)

 
Universal Distribution Center LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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