QUALITY CHOICE MEDICATED PADS- witch hazel cloth

Quality Choice Medicated Pads by

Drug Labeling and Warnings

Quality Choice Medicated Pads by is a Otc medication manufactured, distributed, or labeled by American Hygienics Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Witch Hazel, 50%

Purpose

Astringent

Use

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

Warnings

For external use only. Avoid contact with eyes.

When using this product do not exceed the recommended daily dosage unless directed by a doctor. do not put directly into rectum by using fingers or any mechanical device.

Stop use and ask a 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.

Directions:

As hemorrhoidal treatment for adults:
When practical, clean 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: ask a doctor

Other Information

Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

alcohol, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, water

SPL UNCLASSIFIED SECTION

* Compare to the Active Ingredient in TUCKS® Medicated pads

Hemorrhoidal/Vaginal pads with Witch Hazel

Pre-moistened Pads Provide Temporary Relief of Burning, Itching and Local Discomfort Associated with Hemorrhoids

Other Uses For vaginal care - Cleanse the area by gently wiping, patting or blotting with pad and discard. Repeat as needed.

FOR YOUR PROTECTION, JAR IS SEALED. IF SEAL IS BROKEN OR MISSING, DO NOT USE.

SATISFACTION GUARANTEED 100% QC

Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

Made in China

*This product is not manufactured or distributed by McNEIL-PPC, Inc., owner of the registered trademark TUCKS®.

Packaging

INGREDIENTS AND APPEARANCE

QUALITY CHOICE MEDICATED PADS 
witch hazel cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15533-395
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	0.0086 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15533-395-01	100 in 1 JAR; Type 0: Not a Combination Product	05/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	05/12/2021

Labeler - American Hygienics Corporation (545198454)

Establishment
Name	Address	ID/FEI	Business Operations
American Hygienics Corporation		545198454	manufacture(15533-395)