Label: SHOPKO MAXIMUM STRENGTH MEDICATED WITH ALOE AND 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 July 16, 2013

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  • Active Ingredient

    Witch hazel 50%

  • Purpose

    Astringent

  • Uses

    • helps relieve the local itching and disconfort 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)

  • Directions

    • 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
    •  Dispose of wipe in trash.
    • For best results, only flush one or two wipes at a time.
  • 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

    Aloe, citric acid, Decyl Glucoside, Glycerin, Phenoxyethanol, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Water.


  • Principal Display Panel

    SHOPKO

    Maximum Strength

    Medicated Wipes

    with Aloe and Witch Hazel

    Cools, Soothes and Cofmorts

    For Hemorrhoidal and vaginal Care

    Convenient, Easy to use, Flushable Wipes

    48 Wipes

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


  • INGREDIENTS AND APPEARANCE
    SHOPKO MAXIMUM STRENGTH MEDICATED  WITH ALOE AND WITCH HAZEL
    witch hazel cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-121
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-121-5048 in 1 PACKAGE
    12.9 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/16/2013
    Labeler - Shopko Stores Operating Co., LLC. (023252638)
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