FAMILY CARE MEDICATED HEMORRHOIDAL (WITCH HAZEL) CLOTH [UNITED EXCHANGE CORPORATION]

FAMILY CARE MEDICATED HEMORRHOIDAL (WITCH HAZEL) CLOTH [UNITED EXCHANGE CORPORATION]
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NDC 65923-802-09
Set ID 6a30595a-f864-4ff1-bba0-81ef27ef25b7
Category HUMAN OTC DRUG LABEL
Packager UNITED EXCHANGE CORPORATION
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, 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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