HYDROGEN PEROXIDE- hydrogen peroxide solution 
Vi-Jon, LLC

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.

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Hydrogen Peroxide
871.001-871AA

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 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 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 out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For First aid antiseptic:

  • clean the affected area
  • spray 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

Oral debriding agent (oral rinse): adults, children over 2 years of age:

  • mix with an equal amount of water
  • swish around in the mouth over the affected area for at least 1 minute, then spit out
  • use up to 4 times daily after meals and at bedtime

  • children under 12 years of age should be supervised in the use
  • children 2 years of age: consult a dentist, doctor

Other information

keep tightly closed and at controlled room temperature.  Do not shake bottle.  Hold away from face when opening.

Inactive ingredients

purified water

Distributed by: Vi-Jon, LLC., 8515 Page Ave.

St. Louis, MO 63114

Principal Display Panel

NDC 0869-0871-45

Swan

Hydrogen Peroxide Topical Solution USP

  • First Aid Antiseptic/Oral Debriding Agent
  • For treatment of minor cuts & abrasions
  • For use as a gargle or rinse

Square bottle uses less plastic than a similarly sized round bottle. Recyclable (if available in your area)

DO NOT USE IF HEAT INDUCTION SEAL UNDER CAP IS BROKEN OR MISSING

32 FL OZ (1 QT) 946 mL

image description

Principal Display Panel

Do not use if printed seal under cap is broken or missing

mountain falls

for treatment of minor cuts and abrasions

3% U.S.P.

hydrogen peroxide topical solution USP

first aid antiseptic

oral debriding agent

Made in the USA with US and foreign parts

32 FL OZ (1 QT) 946 mL

image description

HYDROGEN PEROXIDE 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0871
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0869-0871-72295 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/09/2017
2NDC:0869-0871-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/09/2017
3NDC:0869-0871-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/09/2017
4NDC:0869-0871-18118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/09/2017
5NDC:0869-0871-99237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/09/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/09/2017
Labeler - Vi-Jon, LLC (790752542)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(0869-0871)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(0869-0871)

Revised: 1/2023
 
Vi-Jon, LLC