MEDICATED-PADS HEMORRHOIDAL PADS WITH WITCH HAZEL- witch hazel liquid 
Yinjing Medical Technology (Shanghai) Co., Ltd.

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.

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MEDICATED-PADS Hemorrhoidal Pads with Witch Hazel

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.

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

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)

Revised: 12/2017
Document Id: 61592bda-a643-4052-e053-2991aa0a74f8
Set id: 2aec5fb3-5683-4e84-a3b8-e66ea2de534a
Version: 6
Effective Time: 20171227
 
Yinjing Medical Technology (Shanghai) Co., Ltd.