Label: MEDICATED-PADS HEMORRHOIDAL PADS WITH WITCH HAZEL- 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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  • MEDICATED-PADS Hemorrhoidal Pads with Witch Hazel


  • Active ingredient

    Witch Hazel,50% v/v

    Purpose

    Astringent

  • Use

    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.

    Keep out of reach of children.


  • Directions

    ? As a hemorrhoidal treatment for adults and children 12 years of age and older.
    ? 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 then discard. Apply to the affected area up to 6 times daily or after each bowel movement. Children under 12 years of age: consult a doctor.

  • Other information

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

  • Inactive Ingredients:

    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

    NDC: 44019-001-00

    MEDICATED-PADS Hemorrhoidal pads with Witch Hazel IN IN Shanghai Medical Supplies Co.,Ltd. Add: No.586 YuanXi Rd, Nanhui Industry Park, Pudong new area, Shanghai-201300.China. Tel:+86-(21)68016511 Fax:+86-(21)68016736 http://www.yinjing.cn E-mail:zhl@yinjing.cn

  • MEDICATED-PADS Hemorrhoidal Pads with Witch Hazel 1 Wipe (44019-001-00)

    Medicated-Pads Hemorrhoidal pads with witch hazel

  • INGREDIENTS AND APPEARANCE
    MEDICATED-PADS HEMORRHOIDAL PADS WITH WITCH HAZEL 
    witch hazel liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44019-001
    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:44019-001-001 in 1 PACKET08/03/2016
    10.36 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34608/03/2016
    Labeler - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)
    Registrant - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)
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