Label: CVS MEDICATED PADS- witch hazel swab

  • 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 13, 2011

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

  • 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


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  • 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