Label: HEALTH MART MEDICATED COOLING- 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 March 29, 2017

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  • ACTIVE INGREDIENT

    Active ingredient                                          Purpose

    Witch hazel 50%..........................................Astringent

  • PURPOSE

    Uses

    • temporarily relieves the local itching and discomfort associated with hemorrhoids
    • aids in protecting irritated anorectal areas
    • temporarily relieves irritation and burning
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product

    • do not use more than directed unless told to do so by a doctor
    • do not put directly in rectum by using fingers or any mechanical deviec or applicator
  • 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

    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 a soft cloth before applying
    • apply externally to the affected area up to 6 times daily or after each bowl movement
    • after application, discard pad

    Children under 12 years of age: ask a doctor

  • STORAGE AND HANDLING

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

  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Mckesson

    One Post Street

    San Francisco, CA 94104

    www.healthmart.com/healthmartbrand

    Made in China

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HEALTH MART MEDICATED COOLING 
    witch hazel cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0331
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL500 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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:62011-0331-1100 in 1 JAR; Type 0: Not a Combination Product03/29/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/29/2017
    Labeler - Mckesson (Health Mart) (177667227)
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