SHOPKO Medicated Cooling

Manufacturer
Shopko Stores Operating Co., LLC. | PREMIER CARE INDUSTRIES, INC
Effective date
2019-02-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:25

Label at a glance#

ProductSHOPKO Medicated Cooling
Active ingredientWITCH HAZEL
Label structure12 sections

Indications and uses

helps relieve the local itching and discomfort associated with hemorrhoids temporary relief of irritation and burning. aids in protecting irritated anorectal areas.

Dosage and administration

adult: 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 hemorrhoidal treatments, and then discard children under 12 years of age: consult a doctor Dispose of pad in trash after use.Do not flush

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Witch hazel 50%

Purpose

OTC - PURPOSE SECTION

Astringent

Uses

INDICATIONS & USAGE SECTION

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporary relief of irritation and burning.
  • aids in protecting irritated anorectal areas.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • bleeding occurs
  • condition worsens or does not improve within 7 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 Center right away.(1-800-222-1222)

If pregnant or breast-feeding

PREGNANCY SECTION

Ask a health professional before use

Directions

DOSAGE & ADMINISTRATION SECTION

  • adult: 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 hemorrhoidal treatments, and then discard
  • children under 12 years of age: consult a doctor
  • Dispose of pad in trash after use.Do not flush

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 15-300C (59-86°F)
  • for vaginal care - cleanse the area by gently wiping, patting, or blotting.  Repeat as needed.
  • for use as moist compress - if necessary, first cleanse the area as previously described. Fold wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for 15 minutes and repeat as needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Aloe, citric acid, Decyl Glucoside, Glycerin, Phenoxyethanol, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Water.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHOPKO

Compared to the active ingredients in Tucks*

Medicated Cooling Pads

hemorrhoidal pads with witch hazel

  • Fast, soothing relief from Irritation and burning
  • For hemmorhoidal and vaginal care

100 pads 3.0 sq. in. (7.6 sq. cm)


Label
Label


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
37012-211-002021-01-29C16284748780-1ba0f9c33-571e-a910-e053-dadaa90a0b85SHOPKO Medicated Cooling Pads

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37012-211-00SHOPKO Medicated Cooling100 in 1 PACKAGESWAB1002
37012-211-00SHOPKO Medicated Cooling2.9 g in 1 PACKETSWAB2.92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37012-211SHOPKO MEDICATED COOLING (WITCH HAZEL) SWAB [SHOPKO STORES OPERATING CO., LLC.]2Legacy NDC, 2 package rows20190202_48511614-727d-41cb-81cc-3d2baf61b8b6.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
37012-21137012-211-00

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
b45381b4-c0a6-4a92-bf9d-6e87c7f21a8548511614-727d-41cb-81cc-3d2baf61b8b62019-02-01WarningsExact identifier
spl id: b45381b4-c0a6-4a92-bf9d-6e87c7f21a85
spl set id: 48511614-727d-41cb-81cc-3d2baf61b8b6

Reported adverse events (FAERS/openFDA)#

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