Label: B-SURE TRAVELER TOWELETTE- b-sure traveler solution

  • NDC Code(s): 50289-9250-1
  • Packager: Birchwood Laboratories LLC
  • 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 January 10, 2023

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  • Warnings

    For external use only. Stop use and ask doctor if rectal bleeding or continued irratation occurs.

  • Directions

    Gently apply to affected areas by patting and then discard.

  • Inactive Ingredients

    Benzalkonium Chloride, Citric Acid, Glycerin, Methlyparaben, Purified Water, Sodium Citrate

  • Purpose

    Astringent

  • Keep Out of Reach of Children

    Keep out of reach of children.

  • Uses

    Temporary relief of anal itching & burning.

  • Active Ingredients

    Witch Hazel 50%

  • B-SURE Packet

    B-SURE Packet

  • INGREDIENTS AND APPEARANCE
    B-SURE TRAVELER TOWELETTE 
    b-sure traveler solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50289-9250
    Route of AdministrationRECTAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.5 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.125 g  in 1 g
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 0.034 g  in 1 g
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.026 g  in 1 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 0.012 g  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) 0.0009 g  in 1 g
    WATER (UNII: 059QF0KO0R) 0.302 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50289-9250-14 g in 1 PACKET; Type 0: Not a Combination Product01/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01501/20/2020
    Labeler - Birchwood Laboratories LLC (096488432)
    Establishment
    NameAddressID/FEIBusiness Operations
    Birchwood Laboratories LLC096488432manufacture(50289-9250)
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