FDA.reportPublic FDA data

QUALITY CHOICE Medicated Wipes

Manufacturer
American Hygienics Corporation
Effective date
2021-08-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:48

Label at a glance#

ProductQUALITY CHOICE Medicated Wipes
Active ingredientWITCH HAZEL
Label structure9 sections

Indications and uses

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

Dosage and administration

• 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 movem...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Witch hazel 50%

Purpose

OTC - PURPOSE SECTION

Anorectal/Astringent

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medicated WipesMedicated Wipes

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
844379witch hazel 50 % Medicated PadPSN1
844379witch hazel 500 MG/ML Medicated PadSCD1
844379witch hazel 50 % Medicated PadSY1
844379witch hazel 50 % Medicated WipesSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15533-396-012023-07-28C16284748780-10191ceaa-6b6c-198a-e063-dbdaa90aec3eQUALITY CHOICE Medicated Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15533-396-01QUALITY CHOICE Medicated Wipes4.68 mL in 1 PACKAGECLOTH4.681
15533-396-01QUALITY CHOICE Medicated Wipes48 in 1 POUCHCLOTH481

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15533-396QUALITY CHOICE MEDICATED WIPES (WITCH HAZEL) CLOTH [AMERICAN HYGIENICS CORPORATION]1Legacy NDC, 2 package rows20210808_bde399cf-fd37-43e1-9692-b512e14f97b9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15533-39615533-396-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WITCH HAZEL101I4J0U34ACTIB
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
faa7c23b-0edf-4a1c-a374-708856a6cb08bde399cf-fd37-43e1-9692-b512e14f97b92021-08-05WarningsExact identifier
spl id: faa7c23b-0edf-4a1c-a374-708856a6cb08
spl set id: bde399cf-fd37-43e1-9692-b512e14f97b9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.