Label: HYDROGEN PEROXIDE solution

  • NDC Code(s): 61734-010-01, 61734-010-02, 61734-010-03, 61734-010-04, view more
    61734-010-05, 61734-010-06, 61734-010-07
  • Packager: Delon Laboratories (1990) Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

If you are a consumer or patient please visit this version.

  • 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 1 week unless directed by a doctor or dentist

    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 this 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 older:
    • mix with an equal amount of warm 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 the 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

  • Delon Hydrogen Peroxide 3%

    Hydrogen Peroxide 3

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61734-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61734-010-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2014
    2NDC:61734-010-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/201412/07/2014
    3NDC:61734-010-03236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/201412/04/2014
    4NDC:61734-010-04946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/201412/04/2014
    5NDC:61734-010-051000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/201412/04/2014
    6NDC:61734-010-06100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/08/201412/04/2014
    7NDC:61734-010-07175 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/08/201410/31/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02210/08/2014
    Labeler - Delon Laboratories (1990) Ltd (248364184)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoires Delon208896216manufacture(61734-010) , pack(61734-010) , label(61734-010)