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Hydrogen Peroxide by NDC, Inc.

Dosage form: solution
Ingredients: Hydrogen Peroxide 30mg in 1mL
Labeler: NDC, Inc.
NDC Code: 43128-001

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

Drug Facts

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 removal of phlegm, mucous, 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 1 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
First Aid Antiseptic
  • clean the affected area
  • apply a small amount of product on the 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 and children 2 years of age & over:

  • 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

Other Information
  • Keep tightly closed in a cool dark place
  • Do not shake bottle
  • Hold away from face when opening

Inactive Ingredient

Purified Water

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

REF: P903016
NDC 43128-001-16

Hydrogen
Peroxide
3% USP

Tamper evident cap for your protection. If ring-band is
detached from cap or missing do not use.

16 oz. ( 473 mL )

Made in USA for:
NDC, Inc., 407 New Sanford Rd.
La Vergne, TN 37086
www.ProAdvantagebyNDC.com

Pro
ADVANTAGE
®
by NDC

HYDROGEN PEROXIDE 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43128-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrogen Peroxide (Hydrogen Peroxide) Hydrogen Peroxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Packaging
#Item CodePackage Description
1NDC:43128-001-16473 mL in 1 BOTTLE, PLASTIC
2NDC:43128-001-08237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A06/01/2014
Labeler - NDC, Inc. (009831413)

Revised: 11/2017
 
NDC, Inc.

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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.

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