OBSTETRICAL ANTISEPTIC TOWELETTE (BENZALKONIUM CHLORIDE) LIQUID [PSS WORLD MEDICAL, INC.]

OBSTETRICAL ANTISEPTIC TOWELETTE (BENZALKONIUM CHLORIDE) LIQUID [PSS WORLD MEDICAL, INC.]
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NDC 68345-881-50
Set ID 17aa8d03-8765-4690-b43d-60cff6b8c6e5
Category HUMAN OTC DRUG LABEL
Packager PSS World Medical, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
  • ACTIVE INGREDIENT

    Active ingredient                                

    Benzalkonium Chloride, 0.13% w/v

  • PURPOSE

    Purpose

    First Aid Antiseptic

  • INDICATIONS & USAGE

    Use Towelette to help prevent the risk of skin infection.

  • WARNINGS

    Warnings

    For external use only.

    Do not insert into the vagina.

  • DO NOT USE

    Do not use  

    • in the eyes or apply over large areas of the body.
  • STOP USE

    Consult a doctor in case of deep or puncture wounds, animal bites, or serious burns.

    Stop use and consult a doctor if the condition persists or gets worse.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Clean the affected area
    • Apply by gently patting 1 to 3 times daily or as directed by a doctor
    • May be covered with a sterile bandage when dry
  • INACTIVE INGREDIENT

    Inactive ingredient: water, sodium bicarbonate, fragrance, o-phenylphenol

  • QUESTIONS

    Questions or Comments about Select Medical Products? 800-777-4908

  • DESCRIPTION

    Manufactured for PSS World Medical, Inc.

    4345 Southpoint Blvd., Jacksonville, FL 32216

    Made in China 

  • Package Label

    Reorder #268

    NDC 68345-881-50

    268_Each

    268_Each

    268_Box

    268_Box

    268_Case

    268_Case

  • INGREDIENTS AND APPEARANCE
    OBSTETRICAL ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68345-881
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    O-PHENYLPHENOL (UNII: D343Z75HT8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68345-881-5010 in 1 CASE
    1100 in 1 BOX
    11.5 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/19/2013
    Labeler - PSS World Medical, Inc. (101822682)
    Registrant - Shanghai Yinjing Medical Supplies Co., Ltd. (530501535)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Yinjing Medical Supplies Co., Ltd.530501535manufacture(68345-881)

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