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KEEPAN A (Sato Pharmaceutical Co., Ltd.)

Available Formats

Dosage Form Package Information Links
SPRAY 1 BOTTLE, SPRAY in 1 CARTON (49873-019-01) > 60 mL in 1 BOTTLE, SPRAY Label Information

Complete KEEPAN A Information

  • ACTIVE INGREDIENT

    Active ingredients
    Benzalkonium chloride 0.1%
    Lidocaine hydrochloride 1%


  • PURPOSE

    Purpose
    Benzalkonium chloride    First aid antiseptic
    Lidocaine hydrochloride    External analgesic


  • INDICATIONS & USAGE

    Uses  First aid for minor cuts, scrapes and burns:
    â–  to help reduce the risk of infection
    â–  for the temporary relief of pain and itching


  • WARNINGS

    Warnings
    For external use only

    Do not use
    â–  in the eyes    â–  in large quantities
    â–  over large areas of the body    â–  over raw surfaces or blistered areas
    â–  longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have
    â–  deep or puncture wounds â–  animal bites â–  serious burns

    When using this product
    â–  avoid contact with the eyes

    Stop use and ask a doctor if
    â–  condition worsens
    â–  symptoms persist for more than 7 days, or clear up and occur again within a few days
    â–  irritation, redness, swelling or pain persists or increases or a rash or infection develops

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


  • DOSAGE & ADMINISTRATION

    Directions
    Adults and children 2 years of age and older:
    â–  clean the affected area
    â–  spray a small amount directly on the affected area or apply with clean gauze or cotton saturated with KEEPAN A 1 to 3 times daily
    â–  may be covered with a sterile bandage
    â–  if bandaged, let dry first
    Children under 2 years of age: Do not use, consult a doctor.


  • INACTIVE INGREDIENT

    Inactive ingredients  alcohol, fragrance, hydrochloric acid, purified water, sodium chloride, sodium citrate


  • PRINCIPAL DISPLAY PANEL


    keepanAcart.jpg
    carton

  • PRINCIPAL DISPLAY PANEL

    keepanAPDP.jpg
    PDP



  • INGREDIENTS AND APPEARANCE
    KEEPAN A 
    benzalkonium chloride, lidocaine hydrochloride spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-019
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g  in 100 mL
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 1 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49873-019-01 1 in 1 CARTON
    1 60 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 07/15/1981
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    Name Address ID/FEI Business Operations
    Sato Pharmaceutical Co., Ltd. 715699133 manufacture, label, pack