Label: AER PRE-MOISTENED WITCH HAZEL PAD- witch hazel solution

  • NDC Code(s): 50289-3250-1
  • 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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  • Active Ingredient

    Witch Hazel 50%

  • Purpose

    Astringent

  • Uses

    Temporary relief of anal itching and burning

    Temporarily protects irritated tissues

  • Warnings

    For external rectal use only

    Stop use and ask doctor if

    rectal bleeding or continued irritation occurs

  • Keep Out Of Reach of Children

    Keep out of reach of children

  • Directions

    Gently apply to affected areas by patting and then discard

  • Inactive Ingredients

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

  • AER Lid

    AER Lid

  • INGREDIENTS AND APPEARANCE
    AER  PRE-MOISTENED WITCH HAZEL PAD
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50289-3250
    Route of AdministrationTOPICAL, RECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL500 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Color    Score    
    ShapeSize108mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50289-3250-140 in 1 JAR06/28/2018
    12.8 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01506/28/2018
    Labeler - Birchwood Laboratories LLC (096488432)
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