QUALITY CHOICE MEDICATED WIPES- witch hazel cloth

QUALITY CHOICE Medicated Wipes by

Drug Labeling and Warnings

QUALITY CHOICE Medicated Wipes 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

Anorectal/Astringent

Uses

temporarily relieves the local itching and discomfort associated with hemorrhoids
aids in protecting irritated anorectal areas  temporarily relieves irritation and burning

Warnings

For external use only

When using this product
do not use more than directed unless told to do so by a doctor
do not put directly in the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if
rectal bleeding occurs
condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

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

Directions

open the lid on the top of the wipes pouch  peel back wipes seal, remove completely and discard
grab the top wipe at the edge of the center fold and pull out of pouch 
close lid after each use to retain moisture 
adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area
use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard. Do Not Flush.
children under 12 years of age: consult a doctor

Other information

store at room temperature 20-25°C (68-77°F)  protect from excessive heat

Inactive ingredients

alcohol, aloe vera leaf, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

SPL UNCLASSIFIED SECTION

Compare to the Active Ingredient in PREPARATION H®

Hemorrhoidal/Vaginal Wipes with Witch Hazel

Soothes & Comforts Irritated Areas

Pre-moistened Cooling Wipes

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Other Uses:
For external vaginal care – cleanse the area by gently wiping, patting or blotting. Repeat as needed.
For use as a moist compress – if necessary, first cleanse the area. Fold new wipe to desired size and place in contact with irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed.

TAMPER EVIDENT: DO NOT USE IF POUCH IS OPEN OR DAMAGED.

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Preparation H® Medicated Wipes.

**Decolorized. Prop 65.

Made in China

Packaging

INGREDIENTS AND APPEARANCE

QUALITY CHOICE MEDICATED WIPES 
witch hazel cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15533-396
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	50 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15533-396-01	48 in 1 POUCH	07/28/2021
1		4.68 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	07/28/2021

Labeler - American Hygienics Corporation (545198454)

Establishment
Name	Address	ID/FEI	Business Operations
American Hygienics Corporation		545198454	manufacture(15533-396)