FDA.reportPublic FDA data

OLP HEMORRHOIDAL COOLING

Manufacturer
OHIO LAB PHARMA
Effective date
2018-11-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:57:22

Label at a glance#

ProductOLP HEMORRHOIDAL COOLING
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, WITCH HAZEL
Label structure15 sections

Indications and uses

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

Dosage and administration

adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying gel. when first opening the tube, puncture foil seal with top end of cap apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement children under 12 years of age:...

Storage and handling

store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCI, 0.25%

PURPOSE

OTC - PURPOSE SECTION

  • Vasoconstrictor
  • Astringent

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

For external use only

ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking a prescription drug for high blood pressure or depression

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 USING AND ASK YOUR DOCTOR IF

OTC - STOP USE SECTION

  • bleeding occurs
  • condition worsens or does not improve within 7 days

IF PREGNENT OR BREAST-FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying gel.
  • when first opening the tube, puncture foil seal with top end of cap
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years of age: ask a doctor

OTHER INFORMATION

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

edetate disodium, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium metabisulphite

QUESTIONS

OTC - QUESTIONS SECTION

ohiolabpharma.us

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hemorrhoidalhemorrhoidal

COOLING RELIEF
OLP HEMORRHOIDAL COOLING GEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
249465phenylephrine HCl 0.25 % / witch hazel 50 % Rectal GelPSN4
249465phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal GelSCD4
249465phenylephrine 0.25 % / witch hazel 50 % Rectal GelSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70648-009-012020-01-31C16284748780-19d75b9d0-d429-f424-e053-dadaa90a57ce3dc07e6b-803d-1c11-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70648-009-01OLP HEMORRHOIDAL COOLING20 g in 1 TUBEGEL204
70648-009-01OLP HEMORRHOIDAL COOLING1 in 1 CARTONGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70648-009OLP HEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [OHIO LAB PHARMA]4Legacy NDC, 2 package rows20181127_3dc07e6b-803d-1c11-e054-00144ff88e88.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
70648-00970648-009-01

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
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
METHYLPARABENA2I8C7HI9TIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM METABISULFITE4VON5FNS3CIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
WITCH HAZEL101I4J0U34ACTIB

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
7b9c7b3e-3d00-9323-e053-2a91aa0a13da3dc07e6b-803d-1c11-e054-00144ff88e882018-11-26WarningsExact identifier
spl id: 7b9c7b3e-3d00-9323-e053-2a91aa0a13da
spl set id: 3dc07e6b-803d-1c11-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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