Label: WHITE LABS- hydrogen peroxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 1, 2018

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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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