Label: OBSTETRICAL ANTISEPTIC TOWELETTE- benzalkonium chloride 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 June 27, 2013

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  • 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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