FAMILY WELLNESS MEDICATED COOLING PADS (WITCH HAZEL) SOLUTION [FAMILY DOLLAR]

FAMILY WELLNESS MEDICATED COOLING PADS (WITCH HAZEL) SOLUTION [FAMILY DOLLAR]
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NDC 55319-032-10
Set ID f2b23e9d-d1a3-4cc3-8882-381cc763f89c
Category HUMAN OTC DRUG LABEL
Packager FAMILY DOLLAR
Generic Name
Product Class
Product Number
Application Number PART346
  • ACTIVE INGREDIENT

    Active ingredient                                                                 Purpose

    Witch Hazel 50% ...............................................................Astringent

  • PURPOSE

    Uses

    Temporarily relieves these external symptoms associated with hemorrhoids: itching, burning, and irritation

  • WARNINGS

    Warnings

    For external use only.  Avoid contact with eyes.

  • WHEN USING

    When using this product

    • Do not exceed the recommended daily dosage unless directed by a doctor
    • Do not put directly in rectum by using fingers or any mechanical device
  • STOP USE

    Stop use and ask a doctor if

    • Rectal bleeding occurs
    • Condition worsens or does not improve within 7 days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • INDICATIONS & USAGE

    Directions

    • As hemorrhoidal treatment for adults:
    • When practical clean the affected area with mild soap and warm water and rinse thoroughly
    • Gently dry by patting or blotting with toilet tissue or soft cloth before applying
    • Gently apply to the affected area by patting and then discard
    • Can be used up to six times daily or after each bowel movement
    • Children under 12 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    Store at 20o to 25oC (68o to 77oF)

  • INACTIVE INGREDIENT

    Inactive ingredients: alcohol, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, water

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.

    10401 MONROE RD, MATTHEWS, NC 28105 USA

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS MEDICATED COOLING PADS  
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-032
    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
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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:55319-032-10100 in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34609/30/2012
    Labeler - FAMILY DOLLAR (024472631)

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