WHITE LABS (HYDROGEN PEROXIDE) LIQUID [BIOSTECH CO., LTD.]

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WHITE LABS (HYDROGEN PEROXIDE) LIQUID [BIOSTECH CO., LTD.]
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NDC 70812-001-01, 70812-001-02, 70812-001-03, 70812-001-04
Set ID b8dfa7fa-6601-4eb3-9473-02128e1557c1
Category HUMAN OTC DRUG LABEL
Packager BIOSTECH CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART356
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  • ACTIVE INGREDIENT

    Hydrogen Peroxide 2.80%

  • PURPOSE

    Oral Debriding

  • INDICATIONS & USAGE

    Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

  • DOSAGE & ADMINISTRATION

    Use up to 2 times daily after meals and at bedtime

    children under 13 years of age Do not use

  • WARNINGS

    For external use only

  • ASK DOCTOR

    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

    Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

  • INACTIVE INGREDIENT

    Distilated water, Polyvinyl alcohol, Titanium dioxide, Poloxamer 407, Glycerine, PEG400, Ethanol, PVP K29/32(Povidone), PVP K90(Povidone), Aerosil 200, Flavor(Applemint HF62184), Citric Acid, Sodium Citric Acid

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WHITE LABS 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70812-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydrogen Peroxide (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) Hydrogen Peroxide0.42 g  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ALCOHOL (UNII: 3K9958V90M)  
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MENTHA SUAVEOLENS WHOLE (UNII: G0O5N5EA8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70812-001-021 in 1 CARTON04/01/2018
    1NDC:70812-001-0115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70812-001-041 in 1 CARTON04/01/2018
    2NDC:70812-001-0320 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/01/2018
    Labeler - BIOSTECH CO., LTD. (687294330)
    Registrant - BIOSTECH CO., LTD. (687294330)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIOSTECH CO., LTD.687294330manufacture(70812-001)
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