RITEAID HEMORRHOIDAL COOLING

Manufacturer
Rite Aid Corporation | Pharma Pac, LLC
Effective date
2010-11-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:36

Label at a glance#

ProductRITEAID 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)

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

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
11822-0407-92019-11-13C16284748780-197449f38-d073-f6ea-e053-dbdaa90aa703drug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0407-9RITEAID HEMORRHOIDAL COOLING51 g in 1 TUBEGEL511
11822-0407-9RITEAID HEMORRHOIDAL COOLING1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0407RITEAID HEMORRHOIDAL COOLING (WITCH HAZEL, PHENYLEPHRINE HYDROCHLORIDE) GEL [RITE AID CORPORATION]1Legacy NDC, 2 package rows20120502_6c519989-bc4a-4fa6-9b52-75dda424bf03.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
11822-040711822-0407-9

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 · Source PDF

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
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYSTEM / TOPICAL21 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact 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 GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATEANHYDROUS TRISODIUM CITRATERS7A450LGAPOWDER, FOR SUSPENSION / ORAL320 mgExact identifier — unii candidate
30 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45TABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii candidate
7 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUPPOSITORY / RECTAL72.15 mgExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION / INTRAVENOUS1170 mgExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 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
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATEANHYDROUS TRISODIUM CITRATERS7A450LGATABLET / SUBLINGUAL36 mgExact identifier — unii candidate
30 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATEANHYDROUS TRISODIUM CITRATERS7A450LGATABLET, DELAYED RELEASE / ORAL15 mgExact identifier — unii candidate
30 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATEANHYDROUS TRISODIUM CITRATERS7A450LGATABLET / ORAL720 mgExact identifier — unii candidate
30 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAVENOUS0.5 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INFILTRATION0.35 mgExact identifier — unii candidate
68 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / AURICULAR (OTIC)0.2 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45SOLUTION / ORAL34 mgExact identifier — unii candidate
7 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
78 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAMUSCULAR95 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRALESIONAL0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSPRAY / NASAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPASTE, DENTIFRICE / DENTAL0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii candidate
79 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATEANHYDROUS TRISODIUM CITRATERS7A450LGASOLUTION / ORAL240 mgExact identifier — unii candidate
30 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 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
a8cb6669-b661-47b2-a7cf-92603354674b6c519989-bc4a-4fa6-9b52-75dda424bf032010-11-18WarningsExact identifier
spl id: a8cb6669-b661-47b2-a7cf-92603354674b
spl set id: 6c519989-bc4a-4fa6-9b52-75dda424bf03

Reported adverse events (FAERS/openFDA)#

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