PERSONAL CLOTH WIPES- witch hazel swab 
Jiangsu Province JianErKang Medical Dressing 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.

----------

Drug Facts

Active Ingredient

Witch Hazel 50% v/v

Purpose

Astringent

Use

Temporarily relieves these symptoms associated with hemorrhoids

Itching

Burning irritation

Directions

Unfold towelette and cleanse intended skin area thoroughly.

Discard after single use.

Warnings Consult a doctor

If condition worsens of dose not improve within 7 days

In case of bleeding

Before exceeding the recommended dosage

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

Keep out reach of children.

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

Other information

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

Inactive ingredients

Purified Water, Fragrance

Image of Pouch Label

Pouch Label

PERSONAL CLOTH WIPES 
witch hazel swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-2608
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL500 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON (LEMON FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34645-2608-31.4 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)01/01/201008/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/01/201008/21/2018
Labeler - Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. (530968767)

Revised: 8/2018
Document Id: 73f07429-8628-5aab-e053-2a91aa0a0edf
Set id: 8492ef49-db8d-46a2-9a92-c4d908c02e1b
Version: 4
Effective Time: 20180821
 
Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.