Label: ANTIBACTERIAL WET WIPES swab

  • Category: HUMAN OTC DRUG LABEL

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 December 6, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredients:

    Benzalkonium Chloride 0.3%

  • PURPOSE

    Uses:
    Reduces bacteria on the skin. Recommended for repeated use.

  • WARNINGS

    Warnings:

    For external use only.Keep out of eyes.Discontinue use if irritation or redness develops.Keep out of reach of children except with adult

    supervision.Do not flush down toilet.

  • INDICATIONS & USAGE

    Directions:

    Open packet,remove and unfold pre-moistened tissue.Wipe hands including nails and cuticles.Allow to dry without wiping.Discard properly

    after use

  • DOSAGE & ADMINISTRATION

    Other Information

    Do not store above 110F(43C) May discolor certain fabric or surfaces. Harmful to wood finishes and plastics.


  • KEEP OUT OF REACH OF CHILDREN

    Children under 6 years of age should be super vised when using this product.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    water(aqua),Propylene Glycol,Tocopherol,Kathon

  • PRINCIPAL DISPLAY PANEL

    image of antibacterial wet wipes

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WET WIPES 
    antibacterial wet wipes swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 95.5 g  in 100 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 4 g  in 100 g
    TOCOPHEROL (UNII: R0ZB2556P8) 0.1 g  in 100 g
    ISOTHIAZOLINONE (UNII: E57JT172V7) 0.1 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-400-0210 in 1 BOTTLE09/15/2016
    1NDC:47993-400-013 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:47993-400-0430 in 1 BOTTLE09/15/2016
    2NDC:47993-400-033 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:47993-400-0610 in 1 PACKAGE09/15/2016
    3NDC:47993-400-053 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:47993-400-0830 in 1 PACKAGE09/15/2016
    4NDC:47993-400-073 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/15/2016
    Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.,LTD544493972manufacture(47993-400)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!