Label: FAMILY CARE MEDICATED HEMORRHOIDAL- 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 20, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient                                                                                         Purpose

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

  • PURPOSE

    Uses

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

  • WARNINGS

    Warnings

    For external use only.

  • 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 59o to 77oF

  • INACTIVE INGREDIENT

    Inactive ingredient:

    water, glycerin, alcohol, propylene glycol, sodium citrate, diazolidinyl urea, citric acid, methylparaben, and propylparaben

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

    Made in China

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE MEDICATED HEMORRHOIDAL  
    witch hazel cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-802
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-802-098 in 1 CARTON
    11 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/20/2011
    Labeler - UNITED EXCHANGE CORPORATION (840130579)
    Registrant - UNITED EXCHANGE CORPORATION (840130579)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMERICAN HYGIENICS CORPORATION545198454manufacture
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