HYDROGEN PEROXIDE LOTION [CARDINAL HEALTH]

HYDROGEN PEROXIDE LOTION [CARDINAL HEALTH]
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NDC 37205-871-34, 37205-871-43, 37205-871-45
Set ID 219ba811-75cb-4a36-8df8-06c7b7303c2a
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health
Generic Name
Product Class
Product Number
Application Number PART333A
  • 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, mucus, or other secretions associated with occasional sore mouth

  • Warnings

    For external use only

    Do not use

    •in 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 affected area 1 to 3 times a day
    •irritation, pain or redness persists or worsens
    •swelling, rash, or fever develops
    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
    •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 and at controlled room temperature.  Do not shake bottle.  Hold away from face when opening

  • Inactive ingredient

    purified water

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
    www.myleader.com 1-800-200-6313

  • PRINCIPAL DISPLAY PANEL

    Do not use if printed seal under cap is broken or missing
    NDC 32706-871-43
    LEADER
    Hydrogen Peroxide Topical Solution USP
    First Aid Antiseptic
    Oral Debriding Agent
    16 FL OZ (1 PT) 473 mL

    image of principal display panel

    871.001/871AA

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-871
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-871-43.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/12/2012
    2NDC:37205-871-45.946 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/12/2012
    3NDC:37205-871-34.237 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/12/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/12/2012
    Labeler - Cardinal Health (097537435)
    Registrant - Vi-Jon Inc (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, Inc790752542manufacture(37205-871)