Premier Value Medicated Wipes

Manufacturer
Ashtel Studios, Inc.
Effective date
2023-01-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:25

Label at a glance#

ProductPremier Value 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 movement...

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Centre (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 hemorroidal 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

COMPARABLE TO PREPARATION H ACTIVE INGREDIENT

Hemorrhoidal/Vaginal Wipes with Witch Hazel

• Pre-moistened Cooling Wipes

• Soothes & Comforts Irritated Areas

• 6 IN x 5 IN (15.2 cm x 12.7 cm)

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Distributed By: Pharmacy Value Alliance, LLC • 407 East Lancaster Avenue, Wayne, Pa 19087

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

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-028-012025-01-30C16284748780-12cef2736-7907-d83d-e063-dadaa90ab31fPremier Value ®  Medicated Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-028-01Premier Value Medicated Wipes48 in 1 BAGCLOTH482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-028PREMIER VALUE MEDICATED WIPES (WITCH HAZEL) CLOTH [ASHTEL STUDIOS, INC.]2Legacy NDC, 1 package rows20230122_768c242d-6a2a-4419-aa70-7a481ba88f0d.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
70108-02870108-028-01

Ingredients#

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

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

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
e9f6912c-77ef-4435-b5e0-c2b61e63a648768c242d-6a2a-4419-aa70-7a481ba88f0d2023-01-20WarningsExact identifier
spl id: e9f6912c-77ef-4435-b5e0-c2b61e63a648
spl set id: 768c242d-6a2a-4419-aa70-7a481ba88f0d

Reported adverse events (FAERS/openFDA)#

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