MAXIM HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) LIQUID [OSTL, INC.]

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MAXIM HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) LIQUID [OSTL, INC.]
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NDC 69950-005-01
Set ID e3997c87-a7b7-4742-b35a-3c2b1d89e627
Category HUMAN OTC DRUG LABEL
Packager Ostl, Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Drug Facts

  • Active ingredient (by volume)

    Hydrogen peroxide 3%

  • Purpose

    first aid antiseptic/oral debriding agent

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately. (1-800-222-1222)

  • INDICATIONS & USAGE

    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 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

  • DOSAGE & ADMINISTRATION

    Directions

    first aid antiseptic:

    • clean affected area
    • apply small amount of product on affected area 1-3 times a day
    • 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 affected area for atleast 1 minute and then spit out
    • use upto 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 dentist or doctor
  • INACTIVE INGREDIENT

    Inactive ingredient purified water, Phosphoric acid as a stabilizer

  • STORAGE AND HANDLING

    Other information Keep tightly closed and in a dark place at a controlled room temperature. Do not shake bottle. Hold away from face when opening.

    DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN OR REMOVED.

  • SPL UNCLASSIFIED SECTION

    3% Topical Solution USP

    TOPICAL ANTI-INFECTIVE

    • For treatment of minor cuts and abrasions.

    Imported by:

    OSTL INC. 5805, White Oak Ave Suite # 16065

    Encino, CA 91416, USA

    www.ostltrade.com

    Made in India

  • Packaging

    HPL

  • INGREDIENTS AND APPEARANCE
    MAXIM HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69950-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydrogen Peroxide (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) Hydrogen Peroxide30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69950-005-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/15/2015
    Labeler - Ostl, Inc. (020117798)
    Establishment
    NameAddressID/FEIBusiness Operations
    WILSON MEDICINE COMPANY916000287manufacture(69950-005)
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