Label: REXALL MEDICATED WIPESHEMORRHOIDAL WIPE HEMORRHOIDAL WIPES WITH WITCH HAZEL- witch hazel cloth

  • 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 December 2, 2021

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Witch hazel 50%

  • Purpose

    Astringent

  • Uses

    • Helps relieve the local itching and discomfort associated with hemorrhoids
    • Temporary relief of irritation and burning
    • Aids in protecting irritated anorectal areas
  • Warnings

    For external use only

  • When using this product

    • do not exceed the recommended daily dosage unless directed by a doctor
    • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • Stop use and ask a doctor if

    • bleeding occurs
    • condition worsens or does not improve within 7 days
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Open lid and peel back label on top of the wipes pouch
    • Pull out wipe and close lid or reseal label
    • Adult: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area.
    • Use up to 6 times daily or after each bowel movement and before applying hemorrhoidal treatments, and then discard
    • Children under 12 years of age: consult a doctor
  • Other information

    • store at room temperature 20-25°C (68-77°F)
    • for vaginal care - cleanse the area by gently wiping, patting, or blotting. Repeat as needed.
    • for use as moist compress - if necessary, first cleanse the area as previously described. Fold wipe to desire size and place in contact with tissue for a soothing and cooling effect. Leave in place for 15 minutes and repeat as needed.
  • Inactive Ingredients

    Water, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Juice, Ciric Acid, Disodium Cocoamphodiacetate, Iodopropynyl Butylcarbamate, PEG-75 Lanolin, Sodium Citrate, 2-Bomo-2-Nitropropane-1,3-Diol

  • Unclassified Section

    48 Medicated Wipes

    5 in. x 6 in. (12.7 cm x 15.2 cm)

    Flushable Medicated Wipes

    Enriched with Aloe

    Hemorrhoidal wipes with witch hazel

    Since 1903 Rexall(R) is a registered trademark of Rexall Sundown, Inc.

    Made with Advanced Flushable Technology(R) from 100% plant-based materials so they're safe for well-maintained sewers and septics. Not recommended for use with basement pump systems. Flush only one wipe at a time.

    Visit us at: Rexall.com

    or call 1-866-4-REXALL

    PACKAGED FOR DOLGENCORP LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072 USA

    (C) 2017 Advanced Flushable Technology(R) is a registered trademark of Nice-Pak Products, Inc. Made in the USA of domestic and imported materials.

  • Principal Display Panel

    lid

    lid

    flow wrap

    2AA883R

  • INGREDIENTS AND APPEARANCE
    REXALL MEDICATED WIPESHEMORRHOIDAL WIPE   HEMORRHOIDAL WIPES WITH WITCH HAZEL
    witch hazel cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL129 g  in 258 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-105-4848 in 1 CONTAINER01/01/2012
    1258 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/01/2012
    Labeler - Dolgencorp, LLC (068331990)
    Registrant - Nice-Pak Products, Inc. (003778198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nice-Pak Products, Inc.067900167manufacture(55910-105)