HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid 
National Distribution Network (Smart Choice)

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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Drug Facts

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 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 (1-800-222-1222) right away.

Directions

  • For use as a 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
  • For use as an 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. 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

3% U.S.P

Hydrogen Peroxide

First Aid Antiseptic

FL OZ (mL)

Distributed by

National Distribution Network

P.O Box 875

Melville, NY 11747-0875

Questions or Comments?

Call 1-877-753-3935

Monday-Friday 9AM-5PM EST

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

Package Label

Hydrogen peroxide 3%

Smart Choice 3% Hydrogen Peroxide

 

HYDROGEN PEROXIDE  3 PERCENT
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53441-268
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53441-268-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/31/201412/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35610/31/201412/31/2021
Labeler - National Distribution Network (Smart Choice) (045099210)

Revised: 12/2018
 
National Distribution Network (Smart Choice)