HYDROGEN PEROXIDE 3 PERCENT (HYDROGEN PEROXIDE) LIQUID [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]

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HYDROGEN PEROXIDE 3 PERCENT (HYDROGEN PEROXIDE) LIQUID [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]
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NDC 50804-156-16
Set ID cfe9be26-e4a4-413c-a602-2f5948e3bb7a
Category HUMAN OTC DRUG LABEL
Packager Good Sense (Geiss, Destin & Dunn, Inc.)
Generic Name
Product Class
Product Number
Application Number PART356
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  • 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 one week

    Ask a doctor before use if you have

    • deep puncture wounds, animal bites or serious burns

    Stop use and ask a doctor if

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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    For use as a first aid antiseptic:

    • clean affected area
    • apply small amount if product on affected area 1-3 times a day
    • may be covered with a sterile bandage
    • if bandaged, let dry first

    For use as an 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 affected area for at least 1 minute and then spit it out. Do not swallow.
      • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
    • children under 12 years should be supervised in the use of this product
    • children under 2 years of age: consult a doctor or dentist 
  • Other information

    • keep tightly closed and in a dark place at room temperature
    • do not shake bottle. Hold away from face when opening
  • Inactive ingredient

    purified water 

  • Principal Display Panel

    Hydrogen Peroxide 3%

    Topical Solution USP

    • First Aid Antiseptic
    • Oral Debriding Agent

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    Distributed by: Perrigo Direct, Inc. Peachtree City, GA 30269 www.PerrigoDirect.com

    Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

     

  • Package Label

    Hydrogen Peroxide 3%

    GOODSENSE Hydrogen Peroxide 3%

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE  3 PERCENT
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-156
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-156-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/31/2017
    Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836)
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