Glycerin, Lidocaine, Petrolatum, and Phenylephrine Hydrochloride

Manufacturer
ONE2ZEE LIMITED LIABILITY COMPANY | YASH PHARMACEUTICALS
Effective date
2021-02-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:57

Label at a glance#

ProductGlycerin, Lidocaine, Petrolatum, and Phenylephrine Hydrochloride
Active ingredientGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 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 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 a soft cloth before applying this cream. 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

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Glycerin 14.4%
Lidocaine 5%
Phenylephrine HCl 0.25%
White petrolatum 15%

Purpose

OTC - PURPOSE SECTION

  • Protectant
  • Local anesthetic
  • Vasoconstrictor
  • 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
  • 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

  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

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 this cream.
  • 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

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

aloe vera leaf, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monosterate, methylparaben, mineral oil, laureth-23, steareth-2, steareth-20, propyl gallate, propylene glycol, propylparaben, sodium benzoate, tocopherol, alpha.- tocopherol acetate, xanthan gum, water

Other Information:

SPL UNCLASSIFIED SECTION

Store at 20-25°C (68-77°F) Do not use if tamper evident packaging has been breached or is missing.

Distributed by: Wellspring Airmont, NY 10952 U.S.A.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2642220glycerin 14.4 % / lidocaine 5 % / phenylephrine HCl 0.25 % / white petrolatum 15 % Rectal CreamPSN1
2642220glycerin 144 MG/ML / lidocaine 50 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamSCD1
2642220glycerin 14.4 % / lidocaine 5 % / phenylephrine HCl 0.25 % / white petrolatum 15 % Rectal CreamSY1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55629-051-042023-01-30C16284748780-1f386c64a-224a-0266-e053-dadaa90a7c1aGlycerin, Lidocaine, Petrolatum, and Phenylephrine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55629-051-04Glycerin, Lidocaine, Petrolatum, and Phenylephrine Hydrochloride113 g in 1 TUBECREAM1131
55629-051-04Glycerin, Lidocaine, Petrolatum, and Phenylephrine Hydrochloride1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55629-051GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE CREAM [ONE2ZEE LIMITED LIABILITY COMPANY]1Legacy NDC, 2 package rows20210210_e758fe66-8e87-4626-bfeb-71f6faf89a44.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55629-05155629-051-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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
33680bc4-29a8-4475-b9c1-2e0867841ecce758fe66-8e87-4626-bfeb-71f6faf89a442021-02-08WarningsExact identifier
spl id: 33680bc4-29a8-4475-b9c1-2e0867841ecc
spl set id: e758fe66-8e87-4626-bfeb-71f6faf89a44

Reported adverse events (FAERS/openFDA)#

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