Label: EQUALINE MEDICATED WIPES- 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 October 3, 2011

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  • ACTIVE INGREDIENT

    Active ingredient                                                              Purpose

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

  • PURPOSE

    Uses

    For temporary relief of local discomfort itching, burning, and irritation associated with hermorrhoids

  • WARNINGS

    Warnings

    For external use only.  Avoid contact with eyes.

  • ASK DOCTOR

    Consult a doctor

    • if condition worsens or does not improve within 7 days
    • in case of bleeding
    • before exceeding the recommended dosage
  • DO NOT USE

    Do not put this product into rectum using fingers or any mechanical device or applicator.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • 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 and children 12 years and older- Up to 6 times daily or after each bowel movement

    Children under 12- Consult a doctor

    When practical, cleanse 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 each application of this product. 

    Gently apply to the affected area by patting and discard.  Apply to the affected area up to 6 times daily or after each bowel movement.

  • STORAGE AND HANDLING

    Store at room temperature: 15o-30oC (59o-86oF)

  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe barbadensis gel, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY

    SUPERVALU INC

    EDEN PRAIRIE,

    MN 55344 USA

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    EQUALINE MEDICATED WIPES 
    witch hazel cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-412
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-412-7748 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34610/03/2011
    Labeler - SUPERVALU INC (006961411)
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