Label: CLEANSING WIPE / TUBE- sodium chloride swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 17, 2012

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  • Active Ingredient

    Sodium chloride (NaCl) 0.9%

  • Purpose

    Cleansing

  • Use

    Clean affected area

  • Warnings

    For external use only .

    Keep out of reach of children.

  • Directions

    Clean affected area

  • Inactive Ingredients

    Purified Water

  • PRINCIPAL DISPLAY PANEL

    strip399
  • INGREDIENTS AND APPEARANCE
    CLEANSING WIPE / TUBE 
    sodium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35617-399
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (sodium cation - UNII:LYR4M0NH37, chloride ion - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35617-399-011 in 1 PACKET
    12 mL in 1 POUCH
    2NDC:35617-399-0215 mL in 1 TUBE
    3NDC:35617-399-0320 mL in 1 TUBE
    4NDC:35617-399-0430 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34908/12/2012
    Labeler - NANTONG STRIP MEDICAL SUPPLY CO.,LTD. (546585519)
    Establishment
    NameAddressID/FEIBusiness Operations
    NANTONG STRIP MEDICAL SUPPLY CO.,LTD. 546585519manufacture(35617-399)