Label: ASSURED FEMININE ANTI-ITCH- benzocaine and benzalkonium chloride cream 

  • NDC Code(s): 33992-2013-1
  • Packager: Greenbrier International
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzocaine 5%

    Benzalkonium Chloride .13%

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  • PURPOSE

    Purpose

    External analgesic

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  • INDICATIONS & USAGE

    Uses

    ▪ temporarily relieves itching

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  • WARNINGS

    Warnings

    For external use only

    Avoid contact with eyes

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  • STOP USE

    Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

    Do not apply over large areas of the body

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away

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  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and older: Apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a doctor

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  • INACTIVE INGREDIENT

    Inactive Ingredients Purified water, Peg-400, Cetearyl Alcohol, Paraffinum Liquidum, Hydroxpropyl Bisstearyldimonium Chloride, Dimethicone, Glyceryl Stearate & Peg-100 Stearate, Diaziolidinyl Urea, Methyparaben, Propylparaben

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  • INGREDIENTS AND APPEARANCE
    ASSURED  FEMININE ANTI-ITCH
    benzocaine benzalkonium chloride cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:33992-2013
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 5 g  in 100 g
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 130 mg  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    POLYETHYLENE GLYCOL 400  
    CETOSTEARYL ALCOHOL  
    MINERAL OIL  
    HYDROXYPROPYL BISSTEARYLDIMONIUM CHLORIDE  
    DIMETHICONE  
    GLYCERYL MONOSTEARATE  
    PEG-100 STEARATE  
    DIAZOLIDINYL UREA  
    METHYLPARABEN  
    PROPYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:33992-2013-1 21 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 02/15/2013
    Labeler - Greenbrier International (610322518)
    Establishment
    Name Address ID/FEI Business Operations
    Ausmetics Daily Chemicals (Guangzhou) Co. Ltd. 529836561 manufacture(33992-2013)
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