Label: FAMILY WELLNESS MEDICATED WIPES- witch hazel solution

  • 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 3, 2021

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

  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Witch hazel, 50%...............................................................Anorectal/Astringent

  • PURPOSE

    Uses

    temporarily relieves the local itching and discomfort associated with hemorrhoids

    aids in protecting irritated anorectal areas

    temporarily relieves irritation and burning

  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product

    • do not use more than directed unless told to do so by a doctor
    • do not put directly in the rectum by using fingers or any mechanical device or applicator
  • STOP USE

    Stop use and ask a doctor if

    • rectal bleeding occurs
    • condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • open the lid on top of the wipes pouch
    • peel back wipes seal, remove completely and discard
    • grab the top wipe at the edge of the center fold and pull out of pouch
    • close lid after each use to retain moisture
    • adults: 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 topical hemorrhoidal treatments, and then discard. Do Not Flush.
    • children under 12 years of age: consult a doctor
  • STORAGE AND HANDLING

    Other information

    Store at room temperature 20-25°C (68-77°F)

    protect from excessive heat

  • INACTIVE INGREDIENT

    Inactive ingredients

    alcohol, aloe vera leaf, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    FAMILY DOLLAR SERVICES, INC.

    10401 MONROE RD.

    MATTHEWS, NC 28105 USA

    Made in China

  • PRINCIPAL DISPLAY PANEL

    24

  • PRINCIPAL DISPLAY PANEL

    3168

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS MEDICATED WIPES 
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL5 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-031-4848 in 1 POUCH; Type 0: Not a Combination Product09/30/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34609/30/2012
    Labeler - FAMILY DOLLAR (024472631)