FDA.reportPublic FDA data

Quality Choice Medicated Pads

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)
Effective date
2023-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:25

Label at a glance#

ProductQuality Choice Medicated Pads
Active ingredientWITCH HAZEL
Label structure9 sections

Dosage and administration

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

Storage and handling

Store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Witch Hazel, 50%

Purpose

OTC - PURPOSE SECTION

Astringent

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

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 right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
844379witch hazel 50 % Medicated PadPSN2
844379witch hazel 500 MG/ML Medicated PadSCD2
844379witch hazel 50 % Medicated PadSY2
844379witch hazel 50 % Medicated WipesSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-395-012025-01-30C16284748780-12cef2736-ad32-d83d-e063-dadaa90ab31fQUALITY CHOICE Medicated Pads

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-395-01Quality Choice Medicated Pads100 in 1 JARCLOTH1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-395QUALITY CHOICE MEDICATED PADS (WITCH HAZEL) CLOTH [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2Legacy NDC, 1 package rows20230122_b895666e-1068-4f91-9d06-a3ce61e9d1ab.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-395-01EA - Each63868-3953f1dcadd-5e6f-47fc-8a36-c38fc07d742312022-10-06

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-39563868-395-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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

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
3af215a1-c16f-4753-8f4c-480f026fab43b895666e-1068-4f91-9d06-a3ce61e9d1ab2023-01-09WarningsExact identifier
spl id: 3af215a1-c16f-4753-8f4c-480f026fab43
spl set id: b895666e-1068-4f91-9d06-a3ce61e9d1ab

Reported adverse events (FAERS/openFDA)#

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