CVS MEDICATED PADS (WITCH HAZEL) SWAB [CVS PHARMACY]

CVS MEDICATED PADS (WITCH HAZEL) SWAB [CVS PHARMACY]
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NDC 59779-247-50, 59779-247-51
Set ID d3d1d9ab-af3e-4564-ac9f-af9a6d33a221
Category HUMAN OTC DRUG LABEL
Packager CVS PHARMACY
Generic Name
Product Class
Product Number
Application Number PART346
  • ACTIVE INGREDIENT



    Active ingredient                              Purpose
    Witch Hazel 50%.......................................Hemorrhoidal Astringent
  • PURPOSE


    Use

    - for the temporary relief of external itching, burning and irritation associated with hemorrhoids.

  • 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



    Other Information

    - store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)
  • WARNINGS

    Warnings

    For external use only.

    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 and ask a doctor if - rectal 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.
  • DOSAGE & ADMINISTRATION


    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



    Other Information

    - store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)
  • INACTIVE INGREDIENT


    Inactive Ingredients purified water, glycerin, alcohol, propylene glycol, diazolidinyl urea, methylparaben,
    propylparaben, sodium citrate, citric acid.
  • PRINCIPAL DISPLAY PANEL


    c

    d



  • INGREDIENTS AND APPEARANCE
    CVS MEDICATED PADS 
    witch hazel swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-247
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-247-501 in 1 CARTON
    150 in 1 JAR
    2NDC:59779-247-51100 in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34611/13/2011
    Labeler - CVS PHARMACY (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture

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