FREDS ANTISEPTIC WASH (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [PHARMA PAC, LLC]

FREDS ANTISEPTIC WASH (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [PHARMA PAC, LLC]
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NDC 67868-054-39
Set ID 66bb7522-e702-4f74-8b7a-9ac2e1e3650f
Category HUMAN OTC DRUG LABEL
Packager Pharma Pac, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART333A
  • ACTIVE INGREDIENT



    Active ingredient                                    Purpose
    Benzalkonium chloride 0.13%..............................First Aid Antiseptic
    Lidocaine hydrochloride 2%.................................External Antiseptic
  • PURPOSE


    Uses- to help reduce the risk of infection in minor cuts scrapes and burns
    - for the temporary relief of pain and itching associated with minor cuts, scrapes and burns
  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. If swallowed, get medical help
    or contact a Poison Control Center immediately
  • INDICATIONS & USAGE



    Uses


    - to help reduce the risk of infection in minor cuts scrapes and burns
    - for the temporary relief of pain and itching associated with minor cuts, scrapes and burns

    Directions

    - adults and children 2 years and older:

    - use to clean minor cut, scrapes and burns by thoroughly flushing the affected area
    - let air dry
    - cover with adhesive bandage or sterile gauze
    - apply a small amount of this product on the area 1 to 3 times daily

    - children under 2 years: Do not use, consult a doctor


  • WARNINGS


    Warnings For external use only.

    Do not use
    - in large quantities, particularly over raw surfaces or blistered areas

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

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

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


  • DOSAGE & ADMINISTRATION


    Directions

    - adults and children 2 years and older:

    - use to clean minor cut, scrapes and burns by thoroughly flushing the affected area
    - let air dry
    - cover with adhesive bandage or sterile gauze
    - apply a small amount of this product on the area 1 to 3 times daily

    - children under 2 years: Do not use, consult a doctor


  • INACTIVE INGREDIENT



    Inactive Ingredients aloe barbadensis gel, poloxamer 188, sodium chloride, sodium citrate, disodium EDTA, water
  • PRINCIPAL DISPLAY PANEL


    c

  • INGREDIENTS AND APPEARANCE
    FREDS ANTISEPTIC WASH 
    benzalkonium chloride and lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67868-054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67868-054-39177 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333A07/08/2010
    Labeler - Pharma Pac, LLC (140807475)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture

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