QUALITY CHOICE HEMORRHOID- witch hazel cloth
Chain Drug Marketing Association (CDMA)

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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Drug Facts

Active ingredient

Witch Hazel 50%

Purpose

Astringent

Use:

Temporarily relieves these external symptoms associated with hemorrhoids: itching, burning, irritation

Warning

For external use only.

Using this product: Do not exceed the recommended daily dosage unless directed by a doctor. Do not insert into rectum or vagina using fingers or mechanical device.

Stop use and ask doctor if: Rectal bleeding occurs, condition worsens or does not improve within 7 days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Directions

Adults: 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 applying. Gently apply to the affected area by patting and then discard. Can be used up to six times daily or after each bowel movement.

Children under 12 years of age: Consult a doctor.

Other information

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

Inactive ingredients:

Water, Glycerin, Alcohol, Propylene Glycol, Sodium Citrate, Diazolidinyl Urea, Citric Acid, Methylparaben, Propylparaben.

Principal Display Panel - Jar Label

NDC 63868-518-01

QC
QUALITY
CHOICE®

*Compare to the active Ingredient In TUCKS® Medicated Pads

Hemorrhoidal Pads

Medicated Cool Relief

Witch Hazel, 50% - Soothes and Protects

Provides Relief from:

Burning and Itching Caused by Hemorrhoids and Other Rectal and Vaginal Irritations

100 Pads 3.0 in dia (7.62 cm dia)

QUALITY CHOICE HEMORRHOID
witch hazel cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-518
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
witch hazel (UNII: 101I4J0U34) (witch hazel - UNII:101I4J0U34)	witch hazel	500 mg in 1 L

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Alcohol (UNII: 3K9958V90M)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Citrate (UNII: 1Q73Q2JULR)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-518-01	100 in 1 JAR	04/16/2014	08/01/2017
1		0.001 L in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	04/16/2014	08/01/2017

Labeler - Chain Drug Marketing Association (CDMA) (011920774)

Revised: 1/2018

Document Id: 2aba7080-39b7-4e2d-a678-b39fd3a6f4c7

Set id: 42e58a4d-ef42-4153-9390-bfb0c8b5bb6c

Version: 2

Effective Time: 20180124

Chain Drug Marketing Association (CDMA)