Label: MAJOR MEDI-PADS- 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 November 29, 2022

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.(1-800-222-1222)

    If pregnant or breast-feeding

    ask a health professional before use.

  • Directions

    • adult: Cleanse the area by gently wiping, patting or blotting.  If necessary, repeat until all matter is removed from the area.
    • apply externally to the affected area up to 6 times daily or after each bowel movement. After application, discard pad and wash hands.
    • children under 12 years of age:Consult a doctor
    • Dispose of pad in trash after use.
    • Do not flush
  • Other information

    • store at room temperature 15-30°C (59-86°F)
  • Inactive Ingredients

    Water, Alcohol, Glycerin, Phenoxyethanol, Aloe, Decyl Glucoside, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Citric Acid

  • Questions or Comments?

    (800) 616-2471

  • Principal Display Panel

    NDC 0904-6829-60

    MAJOR MEDI-PADS

    Hemorrhoidal Pads with Witch Hazel

    Cools, soothes and helps relieve local discomfort associated with hemorrhoids

    Convenient to use

    100 pads 3.0 in dia (7.5 cm dia)

    Compare to Tucks active ingredient*

    * This product is not manufactured or distrbiuted by McNEIL-PPC, Inc., owner of registered trademark Trucks

    Label

  • INGREDIENTS AND APPEARANCE
    MAJOR MEDI-PADS 
    witch hazel cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6829
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL50 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE (UNII: V5VD430YW9)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6829-60100 in 1 PACKAGE01/25/2019
    12.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/25/2019
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    PREMIER CARE INDUSTRIES, INC858442403manufacture(0904-6829)