Label: FLUSHABLE MEDICATED WIPES HEMORRHOIDAL PADS WITH WITCH HAZEL AND ALOE- witch hazel liquid

  • 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 December 27, 2017

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  • Flushable Medicated Wipes Hemorrhoidal Pads with Witch Hazel and Aloe


  • Active ingredient

    Witch Hazel,50% v/v

    Purpose

    Astringent

  • Uses

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

  • Warnings

    For external use only. Avoid contact with eyes.

    Consult a doctor

    • If condition worsens or does not improve within 7 days.
    • In case of bleeding.
    • Before exceeding the recommended dosage.
    • Do not put this product into rectum using fingers or any mechanical device or applicator.
    • If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    ?If swallowed, get medical help or contact a Poison Control Center right away.

  • 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
  • Other information

    Store at room temperature 15 0 - 30 0 C (59 0 - 86 0 F)

  • Inactive Ingredient

    Purified Water, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Juice, Benzalkonium Chloride, Diazolidinyl Urea, Methyl Paraben, Propyl Paraben, Sodium Citrate, Citric Acid, Disodium EDTA.

  • PRINCIPAL DISPLAY PANEL

    IN IN NDC:

    Flushable Medicated Wipes 48 Medicated Wipes 5in*6in (12.7cmx15.2cm) Hemorrhoidal pads with Witch Hazel and Aloe For gental every cleaning to reduce irritation Cools, smoothes and Help Relieve Discomfort from Hemorrhoids For use with Hemorrhoids and Vaginal care convenient and Easy Use.

  • Flushable Medicated Wipes Hemorrhoidal Pads with Witch Hazel and Aloe 48 Wipes (44019-002-00)

    Medicated Wipes

  • INGREDIENTS AND APPEARANCE
    FLUSHABLE MEDICATED WIPES HEMORRHOIDAL PADS WITH WITCH HAZEL AND ALOE 
    witch hazel liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44019-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL50 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44019-002-0048 in 1 BAG08/03/2016
    12.9 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/08/2013
    Labeler - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)
    Registrant - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)
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