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Hydrogen Peroxide by Pioneer Associates

Medically reviewed on August 24, 2017

Dosage form: solution
Ingredients: HYDROGEN PEROXIDE 3mL in 100mL
Labeler: Pioneer Associates
NDC Code: 53033-003

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.

CAVALIER HYDROGEN PEROXIDE

Active ingredient (by volume)

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
  • on deep or puncture wounds, animal bites or on serious burns

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
  • swelling, rash or fever develops
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens

Keep this and all drugs out of reach of children.

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

Directions

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 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 bottle tightly closed and in a dark place at a controlled room temperature.
  • Do not shake bottle.
  • Hold away from face when opening.

Inactive ingredient

Water

PRINCIPAL DISPLAY PANEL

CAVALIER HYDROGEN PEROXIDE SOLUTION

FIRST AID ANTISEPTIC/ORAL DEBRIDING AGENT

16 FL.OZ (473 mL)

HYDROGEN PEROXIDE 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53033-003
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:53033-003-08100 mL in 1 BOTTLE, PLASTIC
2NDC:53033-003-01119 mL in 1 BOTTLE, PLASTIC
3NDC:53033-003-02178 mL in 1 BOTTLE, PLASTIC
4NDC:53033-003-09200 mL in 1 BOTTLE, PLASTIC
5NDC:53033-003-03237 mL in 1 BOTTLE, PLASTIC
6NDC:53033-003-10250 mL in 1 BOTTLE, PLASTIC
7NDC:53033-003-11266 mL in 1 BOTTLE, PLASTIC
8NDC:53033-003-04295 mL in 1 BOTTLE, PLASTIC
9NDC:53033-003-05354 mL in 1 BOTTLE, PLASTIC
10NDC:53033-003-06414 mL in 1 BOTTLE, PLASTIC
11NDC:53033-003-07473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/24/2012
Labeler - Pioneer Associates (012604336)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(53033-003)

 
Pioneer Associates

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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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