FDA.reportPublic FDA data

Reeses

Manufacturer
Reese Pharmaceutical Co | Guy & O'Neill, Inc.
Effective date
2017-10-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:15

Label at a glance#

ProductReeses Pinworm Itch Relief
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

Temporarily relieves itching

Storage and handling

Store at room temperature Discard within 2 months of opening

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine Hydrochloride 1.0% w/w

Purpose

OTC - PURPOSE SECTION

ANALGESIC

Uses

INDICATIONS & USAGE SECTION

  • Temporarily relieves itching

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens or does not improve within 7 days or clears up and reoccurs within a few days

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Direction

DOSAGE & ADMINISTRATION SECTION

  • Adults: unfold wipe and cleanse the area by gently wiping or patting external area from front to back. Use each wipe only once and discard.
  • Use up to 5 times daily.
  • Children under 12: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature
  • Discard within 2 months of opening

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, glycerin, propylene glycol, cocoamphodiacetate, polysorbate 20, aloe vera barbadensis leaf juice, citric acid, fragrance, diazolidinyl urea, iodopropynyl butylcarbamate.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-321-7178

Images of representative packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image on cartonimage on carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039541pramoxine HCl 1 % Medicated PadPSN1
1039541pramoxine hydrochloride 10 MG/ML Medicated PadSCD1
1039541pramoxine hydrochloride 1 % Medicated PadSY1
1039541pramoxine hydrochloride 1 % Medicated WipeSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10956-799-202023-01-30C16284748780-1f386c649-a624-0266-e053-dadaa90a7c1aReeses PINWORM Itch Relief - Drug Facts Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10956-799-20ReesesPinworm Itch Relief89 g in 1 PACKAGECLOTH891

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10956-799REESES PINWORM ITCH RELIEF (PRAMOXINE HYDROCHLORIDE) CLOTH [REESE PHARMACEUTICAL CO]1Legacy NDC, 1 package rows20180711_9ee60214-2cda-43a2-8fc9-5ab78c01acaf.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
10956-79910956-799-20

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
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
POLYSORBATE 207T1F30V5YHIACT
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT

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
7d935f99-18bd-4d0d-93c1-cea254d12cb19ee60214-2cda-43a2-8fc9-5ab78c01acaf2017-10-02WarningsExact identifier
spl id: 7d935f99-18bd-4d0d-93c1-cea254d12cb1
spl set id: 9ee60214-2cda-43a2-8fc9-5ab78c01acaf

Reported adverse events (FAERS/openFDA)#

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