WESTERN FAMILY HYGIENIC CLEANSING (WITCH HAZEL) CLOTH [WESTERN FAMILY FOODS, INC]

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WESTERN FAMILY HYGIENIC CLEANSING (WITCH HAZEL) CLOTH [WESTERN FAMILY FOODS, INC]
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NDC 55312-776-00
Set ID d45e5b62-dc67-4e58-b12f-7c0e06791dcb
Category HUMAN OTC DRUG LABEL
Packager Western Family Foods, Inc
Generic Name
Product Class
Product Number
Application Number PART346
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  • ACTIVE INGREDIENT

    Active ingredient                                            Purpose

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

  • PURPOSE

    Uses

    Temporarily relieves the 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
  • KEEP OUT OF REACH OF CHILDREN

    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 Poision 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
  • ASK DOCTOR

    Children under 12 years of age: ask a doctor

  • STORAGE AND HANDLING

    Other information: store at 20° to 25°C (68° to 77°F)

  • INACTIVE INGREDIENT

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

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Western Family Foods, Inc.

    P.O. Box 4057

    Portland, OR 97208 USA

    www.westernfamily.com

    Made in China

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY HYGIENIC CLEANSING 
    witch hazel cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-776
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.5 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    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:55312-776-00100 in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/10/2015
    Labeler - Western Family Foods, Inc (192166072)
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