REXALL HEMORRHOIDAL COOLING

Manufacturer
DOLLAR GENERAL | Pharma Pac, LLC
Effective date
2010-11-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:37

Label at a glance#

ProductREXALL HEMORRHOIDAL COOLING
Active ingredientWITCH HAZEL, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                                        Purpose

Phenylephrine hydrochloride 0.25%.............................Vasoconstrictor
Witch hazel 50.0%.....................................................Astringent

OTC - PURPOSE SECTION


Uses

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

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.

INDICATIONS & USAGE SECTION


Uses

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

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

WARNINGS SECTION

Warnings

For external use only.

Ask a doctor before use if you have

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

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
- do not put into rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if
- bleeding occurs
- condition worsens or does not improve within 7 days

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

Keep out of the 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 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


INACTIVE INGREDIENT SECTION

Inactive Ingredients aloe barbadensis leaf juice, benzophenone-4, disodium EDTA,
hydroxyethylcellulose. methylparaben, polysorbate 80, propylene glycol, propylparaben,
purified water, sodium citrate, tocopheryl acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


c
c


DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
249465phenylephrine HCl 0.25 % / witch hazel 50 % Rectal GelPSN1
249465phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal GelSCD1
249465phenylephrine 0.25 % / witch hazel 50 % Rectal GelSY1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-603-612019-11-13C16284748780-197449f38-b98d-f6ea-e053-dbdaa90aa703drug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-603-61REXALL HEMORRHOIDAL COOLING51 g in 1 TUBEGEL511
55910-603-61REXALL HEMORRHOIDAL COOLING1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-603REXALL HEMORRHOIDAL COOLING (WITCH HAZEL, PHENYLEPHRINE HYDROCHLORIDE) GEL [DOLLAR GENERAL]1Legacy NDC, 2 package rows20120502_fde1627c-b40b-4a35-830f-bf791c64f84b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
WITCH HAZELACTIVE INGREDIENT101I4J0U341
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
WITCH HAZELACTIVE MOIETY101I4J0U341
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
ANHYDROUS TRISODIUM CITRATEINACTIVE INGREDIENTRS7A450LGA1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)INACTIVE INGREDIENTZYD53NBL451
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SULISOBENZONEINACTIVE INGREDIENT1W6L629B4K1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-60355910-603-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 430 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45GEL / TOPICAL231 mgExact identifier — unii candidate
7 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSHAMPOO / TOPICAL0.03 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION, CONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION/ DROPS / OPHTHALMIC0.01 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATEANHYDROUS TRISODIUM CITRATERS7A450LGAINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS240 mgExact identifier — unii candidate
30 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRALESIONAL0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATEANHYDROUS TRISODIUM CITRATERS7A450LGAFILM / SUBLINGUAL4 mgExact identifier — unii candidate
30 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INFILTRATION0.35 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
68 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATEANHYDROUS TRISODIUM CITRATERS7A450LGASYRUP / ORAL156 mgExact identifier — unii candidate
30 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / INTRAVENOUS900 mgExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHENEMA / RECTAL0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATEANHYDROUS TRISODIUM CITRATERS7A450LGAPOWDER, FOR SOLUTION / ORAL48 mg/5mlExact identifier — unii candidate
30 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE / ORAL418.37 mgExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAMUSCULAR7459 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATEANHYDROUS TRISODIUM CITRATERS7A450LGASOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATEANHYDROUS TRISODIUM CITRATERS7A450LGATABLET / ORAL720 mgExact identifier — unii candidate
30 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHFILM / BUCCAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRABURSAL0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATEANHYDROUS TRISODIUM CITRATERS7A450LGATABLET, CHEWABLE / ORAL72.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HELIXIR / ORAL2.5 mg/15mlExact identifier — unii candidate
78 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLIQUID / INTRAVENOUS720 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / OPHTHALMIC8 mgExact identifier — unii candidate
78 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATEANHYDROUS TRISODIUM CITRATERS7A450LGATABLET / SUBLINGUAL36 mgExact identifier — unii candidate
30 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / SOFT TISSUE4 mgExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION, CONCENTRATE / ORAL0.2 mg/1mlExact identifier — unii candidate
68 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRALESIONAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates

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
e6cb14cb-b299-4697-a448-a98a4f161064fde1627c-b40b-4a35-830f-bf791c64f84b2010-11-18WarningsExact identifier
spl id: e6cb14cb-b299-4697-a448-a98a4f161064
spl set id: fde1627c-b40b-4a35-830f-bf791c64f84b

Reported adverse events (FAERS/openFDA)#

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