FDA.reportPublic FDA data

SHOPKO Maximum Strength Medicated

Manufacturer
Shopko Stores Operating Co., LLC.
Effective date
2013-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:36:09

Label at a glance#

ProductSHOPKO Maximum Strength Medicated with Aloe and Witch Hazel
Active ingredientWITCH HAZEL
Label structure11 sections

Indications and uses

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

Dosage and administration

adult: 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 hemorrhoidal treatments, and then discard  Dispose of wipe in trash. For best results, only flush one or two wipes at a time.

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 disconfort 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)

Directions

DOSAGE & ADMINISTRATION SECTION

  • adult: 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 hemorrhoidal treatments, and then discard
  •  Dispose of wipe in trash.
  • For best results, only flush one or two wipes at a time.

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 20-25°C (68-77°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 desire 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

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


Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHOPKO

Maximum Strength

Medicated Wipes

with Aloe and Witch Hazel

Cools, Soothes and Cofmorts

For Hemorrhoidal and vaginal Care

Convenient, Easy to use, Flushable Wipes

48 Wipes

6 in. x 5 in. (15.2 cm x 12.7 cm)Untitleddd.jpgUntitleddd.jpg


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
37012-121-502020-01-31C16284748780-19d75b9cf-e771-f424-e053-dadaa90a57ceSHOPKO Maximum Strength Medicated wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37012-121-50SHOPKO Maximum Strength Medicatedwith Aloe and Witch Hazel48 in 1 PACKAGECLOTH481
37012-121-50SHOPKO Maximum Strength Medicatedwith Aloe and Witch Hazel2.9 g in 1 PACKETCLOTH2.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37012-121SHOPKO MAXIMUM STRENGTH MEDICATED WITH ALOE AND WITCH HAZEL (WITCH HAZEL) CLOTH [SHOPKO STORES OPERATING CO., LLC.]1Legacy NDC, 2 package rows20130717_321442c2-e42b-453f-b108-0b180b79b81c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
WITCH HAZELACTIVE INGREDIENT101I4J0U341
WITCH HAZELACTIVE MOIETY101I4J0U341
ALOE ARBORESCENS LEAFINACTIVE INGREDIENT09TD8L5SQV1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6Y1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37012-12137012-121-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WITCH HAZEL101I4J0U34ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DECYL GLUCOSIDEZ17H97EA6YIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM BENZOATEOJ245FE5EUIACT
ALOE ARBORESCENS LEAF09TD8L5SQVIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 285 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM / SUBLINGUAL10 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRATHECALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / AURICULAR (OTIC)0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / OPHTHALMIC0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLOTION / TOPICAL0.85 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSWAB / TOPICAL0.05 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION / INTRAMUSCULAR864 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, COATED / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, EXTENDED RELEASE / TRANSDERMAL58.13 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION, CONCENTRATE / INTRAVENOUSNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCONCENTRATE / ORAL5.3 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM / BUCCAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPOINTMENT / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARNAExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO, SUSPENSION / TOPICAL0.25 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates

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
75c97544-0b3e-411b-a9d3-b87a646a6384321442c2-e42b-453f-b108-0b180b79b81c2013-07-16WarningsExact identifier
spl id: 75c97544-0b3e-411b-a9d3-b87a646a6384
spl set id: 321442c2-e42b-453f-b108-0b180b79b81c

Reported adverse events (FAERS/openFDA)#

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