FDA.reportPublic FDA data

Rexall Maximum Strength Hemorrhoidal

Manufacturer
Dolgencorp, Inc. | Anicare Pharmaceuticals Pvt. Ltd
Effective date
2016-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:28

Label at a glance#

ProductRexall Maximum Strength Hemorrhoidal
Active ingredientGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients  
Glycerin 14.4%
Petrolatum 15%
Phenylephrine Hydrochloride 0.25%
Pramoxine HCl 1%

OTC - PURPOSE SECTION

Purpose

Protectant
Protectant
Vasoconstrictor
Local anesthetic

INDICATIONS & USAGE SECTION

Uses

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporary relieves burning
  • aid in protecting irritated anorectal areas

WARNINGS SECTION

Warnings

For external use only.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure 
  • diabetes 
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

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

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product into rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • bleeding occurs
  • condition gets worse or does not improve within 7 days

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults: when practical, cleanse  and gently dry the affected area by patting or blotting with an appropriate cleansing tissue or soft cloth before applying.
  • 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

SPL UNCLASSIFIED SECTION

Other information

  • store at 20°- 25°C (68°- 77°F)
  • for lot number and expiration date, see crimp of tube or see box

INACTIVE INGREDIENT SECTION

Inactive ingredients

aloe barbadensis leaf, cetearyl alcohol, cetyl alcohol, glycerol monostearate,  mineral oil, peg 40 castor oil, propylene glycol, purified water, 
stearyl alcohol, tocopheryl acetate (Vitamin E).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

REXALL MAXIMUM STRENGTH HEMORRHOIDAL

NET WT 1 OZ (28 g)

label of rexalllabel of rexall

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
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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-406-032020-01-31C16284748780-19d75b9d0-4186-f424-e053-dadaa90a57ceRexall Maximum Strength Hemorrhoidal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-406-03Rexall Maximum Strength Hemorrhoidal28 g in 1 TUBECREAM281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-406REXALL MAXIMUM STRENGTH HEMORRHOIDAL (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [DOLGENCORP, INC.]1Legacy NDC, 1 package rows20160702_68c364eb-ca88-4885-8d9e-6ec512266f0a.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-40655910-406-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MINERAL OILT5L8T28FGPIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXACTIB
PETROLATUM4T6H12BN9UACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB

Source Document#

Source XML · Source PDF

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
36a96992-0a52-1323-e054-00144ff88e8868c364eb-ca88-4885-8d9e-6ec512266f0a2016-07-01WarningsExact identifier
spl id: 36a96992-0a52-1323-e054-00144ff88e88
spl set id: 68c364eb-ca88-4885-8d9e-6ec512266f0a

Reported adverse events (FAERS/openFDA)#

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