FDA.reportPublic FDA data

Hemorrhoidal Cream Anesthetic

Manufacturer
Purity Products | Natureplex
Effective date
2016-10-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:48

Label at a glance#

ProductHemorrhoidal Anesthetic
Active ingredientGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM
Label structure9 sections

Indications and uses

For temporary relief of pain, soreness and burning Helps relieve the local itching and discomfort associated with hemorrhoids Temporarily shrinks hemorrhoidal tissue and relieves burning Temporarily provides a coating for relief of anorectal discomforts Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

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 soft cloth before applying the cream When first opening the tube, remove the foil seal Apply externally or in the lower portion of the anal canal only Apply externally to the affected area up to 4 times daily, especially at night, in the morning, or after e...

Storage and handling

Store at 15 to 30°C (59 to 86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurposes
Glycerin 14.4%Protectant
Phenylephrine HCl 0.25%Vasoconstrictor
Pramoxine HCl 1%Local Anesthetic
White petrolatum 15%Protectant

Uses

INDICATIONS & USAGE SECTION

  • For temporary relief of pain, soreness and burning
  • Helps relieve the local itching and discomfort associated with hemorrhoids
  • Temporarily shrinks hemorrhoidal tissue and relieves burning
  • Temporarily provides a coating for relief of anorectal discomforts
  • Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

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 urinating due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are 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 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 the condition worsens or does not improve within 7 days
  • An allergic reaction develops
  • The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 soft cloth before applying the cream
  • When first opening the tube, remove the foil seal
  • Apply externally or in the lower portion of the anal canal only
  • Apply externally to the affected area up to 4 times daily, especially at night, in the morning, or after each bowel movement
  • For application in the lower anal canal; remove the cover from the dispensing cap. Attach the dispensing cap to the tube. Lubricate the dispensing cap well, then gently insert the dispensing cap partway into the anus.
  • Thoroughly cleanse the dispensing cap after each use, and replace the cover
  • Children under 12 years: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • Store at 15 to 30°C (59 to 86°F)

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, cetyl alcohol, edetate disodium, glyceryl monostearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethyl cellulose, steareth-2, steareth-20, stearyl alcohol, vitamin E acetate, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

To Reorder Call: 1-800-281-7781, Customer Care: 1-888-769-7873 or www.purityproducts.com

PRINCIPAL DISPLAY PANEL - 25.5 G Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NET WT.
0.9 OZ (25.5 G)

Save
Uranus

RAPID
SOOTHING
Relief & Comfort

MAXIMUM STRENGTH FOR PAINFUL
BURNING, ITCHING, & DISCOMFORT.

PRINCIPAL DISPLAY PANEL - 25.5 G Tube Carton
PRINCIPAL DISPLAY PANEL - 25.5 G Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1293649glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal CreamPSN1
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD1
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY1

DailyMed Pharmacologic Classes#

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

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
71003-001-012025-01-30C16284748780-12cef2736-a57b-d83d-e063-dadaa90ab31fHemorrhoidal Cream Anesthetic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71003-001-01HemorrhoidalAnesthetic25 g in 1 TUBECREAM251
71003-001-01HemorrhoidalAnesthetic1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71003-001HEMORRHOIDAL ANESTHETIC (GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, AND PETROLATUM) CREAM [PURITY PRODUCTS]1Legacy NDC, 2 package rows20161026_fe25bc32-e37a-45ab-887c-f0332b6cf990.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71003-00171003-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
PETROLATUM4T6H12BN9UACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LAURETH-23N72LMW566GIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PANTHENOLWV9CM0O67ZIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM BENZOATEOJ245FE5EUIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
STEARETH-2V56DFE46J5IACT
STEARETH-20L0Q8IK9E08IACT
STEARYL ALCOHOL2KR89I4H1YIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT

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
ec8baea0-4012-4619-bb68-91cc10cd2fdafe25bc32-e37a-45ab-887c-f0332b6cf9902016-10-25WarningsExact identifier
spl id: ec8baea0-4012-4619-bb68-91cc10cd2fda
spl set id: fe25bc32-e37a-45ab-887c-f0332b6cf990

Reported adverse events (FAERS/openFDA)#

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