HYDROGEN PEROXIDE SOLUTION [HEALTHWELL]

HYDROGEN PEROXIDE SOLUTION [HEALTHWELL]
PDF | XML

NDC 87010-001-16, 87010-001-32
Set ID f654523f-69d5-42eb-90a7-ad2fb9584ea3
Category HUMAN OTC DRUG LABEL
Packager Healthwell
Generic Name
Product Class
Product Number
Application Number PART333A
  • SPL UNCLASSIFIED SECTION

    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 the 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 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

  • PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

    Tamper evident cap for your protection

    if ring-band is broken or missing, do not use.

    Part # HSN2239

    NDC #87010-001-32

    HYDROGEN PEROXIDE

    3% USP 10 VOLUME

    3%

    FIRST AID ANTISEPTIC
    Made in USA

    32 FL. OZ. (946 mL)

    peroxide

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:87010-001
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:87010-001-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/07/2018
    2NDC:87010-001-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/1993
    Labeler - Healthwell (004227758)

Related Drugs