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Hydrogen Peroxide by Delon Laboratories (1990) Ltd

Dosage form: solution
Ingredients: HYDROGEN PEROXIDE 3mL in 100mL
Labeler: Delon Laboratories (1990) Ltd
NDC Code: 61734-010

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 3%

Active ingredient

Hydrogen Peroxide 3%

Purpose

first aid antiseptic / oral debriding agent

Indications
  • 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 unless directed by a doctor or dentist

Ask a physician before use if you have
  • you have deep or puncture wounds, animal bites or serious burns.

Stop use and ask a physician 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 daily
  • 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 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

HYDROGEN PEROXIDE 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61734-010
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 
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:61734-010-01473 mL in 1 BOTTLE, PLASTIC
2NDC:61734-010-02118 mL in 1 BOTTLE, PLASTIC
3NDC:61734-010-03236 mL in 1 BOTTLE, PLASTIC
4NDC:61734-010-04946 mL in 1 BOTTLE, PLASTIC
5NDC:61734-010-051000 mL in 1 BOTTLE, PLASTIC
6NDC:61734-010-06100 mL in 1 BOTTLE, SPRAY
7NDC:61734-010-07175 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/08/2014
Labeler - Delon Laboratories (1990) Ltd (248364184)
Establishment
NameAddressID/FEIOperations
Delon Laboratories (1990) Ltd243387722label(61734-010), manufacture(61734-010), pack(61734-010)

 
Delon Laboratories (1990) Ltd

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Medically reviewed on Oct 16, 2018

Further information

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

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