Hemorrhoidal Cooling Gel

Manufacturer: Amerisource Bergen
Effective date: 2010-01-04
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:23:11

Label at a glance#

ProductHemorrhoidal Cooling Gel

Active ingredientPHENYLEPHRINE HYDROCHLORIDE, WITCH HAZEL

Label structure8 sections

Indications and uses

Helps relieve the local itching and discomfort associated with hemorrhoids Temporary relief of itching and burning Temporarily shrinks hemorrhoidal tissue Aids in protecting irritated anorectal areas

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 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: ask a...

Storage and handling

Store at room temperature: 20° - 25° C (68° - 77° F)

Contacts and useful links#

Websitewww.mygnp.com

www.myGNP.com

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCI, 0.25%
Witch Hazel, 50%

PURPOSE

OTC - PURPOSE SECTION

Vasoconstrictor
Astringent

USES

INDICATIONS & USAGE SECTION

Helps relieve the local itching and discomfort associated with hemorrhoids
Temporary relief of itching and burning
Temporarily shrinks hemorrhoidal tissue
Aids in protecting irritated anorectal areas

WARNINGS

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

heart disease
thyroid disease
high blood pressure
diabetes
difficulty in urination due to enlargement of the prostate

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently 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 using fingers or any mechanical device or applicator

Stop use and ask a doctor

OTC - STOP USE SECTION

if bleeding occurs
condition worsens or does not improve within 7 days

WARNINGS SECTION

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 a 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: ask a doctor.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store at room temperature: 20° - 25° C (68° - 77° F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

aloe barbadensis gel, benzophenone-4, edetate disodium, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, sodium citrate, vitamin E, water

PACKAGE INFORMATION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOOD NEIGHBOR PHARMACY

NDC 24385-421-06

HEMORRHOIDAL
Cooling Gel
with Vitamin E and Aloe

Fast cooling relief from painful burning and itching

Net Wt. 0.9 oz. (26 g)

Fast cooling relief

Clear, non-greasy formula with no unpleasant scent
Prompt cooling relief from painful burning and itching
Shrinks swollen hemorrhoidal tissue
Relieves external discomfort

*Compare to active ingredients in Preparation H® Cooling Gel

FOR YOUR SAFETY, TUBE IS SEALED. DO NOT USE IF TUBE SEAL UNDER CAP IS BROKEN OR MISSING.

*This product is not manufactured or distributed by Wyeth Consumer Healthcare, Inc., owner of the registered trademark Preparation H®.

Distributed By
AmerisourceBergen
Valley Forge, PA 19482-0959

Visit us at www.myGNP.com

carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
249465	phenylephrine HCl 0.25 % / witch hazel 50 % Rectal Gel	PSN	1
249465	phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal Gel	SCD	1
249465	phenylephrine 0.25 % / witch hazel 50 % Rectal Gel	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
24385-421-06	2019-10-21	C162847	48780-1	956f9ecf-dcb9-621f-e053-dbdaa90a74ad	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24385-421-06	Hemorrhoidal Cooling Gel	1 in 1 BOX	GEL	1		1
24385-421-06	Hemorrhoidal Cooling Gel	26 g in 1 TUBE	GEL	26		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24385-421	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1	Legacy NDC, 2 package rows	20100105_ca59ecb1-2a80-41f3-a0c8-816e1590c611.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24385-421-06	GM - Gram	24385-421	0c174c9b-6c82-4bea-a163-9f3c211d71be	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	1
WITCH HAZEL	ACTIVE INGREDIENT	101I4J0U34	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	1
WITCH HAZEL	ACTIVE MOIETY	101I4J0U34	1
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	1
SULISOBENZONE	INACTIVE INGREDIENT	1W6L629B4K	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Hemorrhoidal Cooling Gel
phenylephrine and witch hazel
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
ALOE VERA LEAF
SULISOBENZONE
EDETATE DISODIUM
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
METHYLPARABEN
POLYSORBATE 80
PROPYLENE GLYCOL
PROPYLPARABEN
SODIUM CITRATE
.ALPHA.-TOCOPHEROL ACETATE, D-
WATER
WITCH HAZEL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
24385-421	24385-421-06

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
ALOE VERA LEAF	ZY81Z83H0X	IACT
SULISOBENZONE	1W6L629B4K	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	S38J6RZN16	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
.ALPHA.-TOCOPHEROL ACETATE, D-	A7E6112E4N	IACT
WATER	059QF0KO0R	IACT
WITCH HAZEL	101I4J0U34	ACTIB

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 7 · 398 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRASYNOVIAL	0.2 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	PASTE / ORAL		28 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED / ORAL	24 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LOTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / NASAL	14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAMUSCULAR		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SUSPENSION / TOPICAL	0.69 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SUSPENSION / AURICULAR (OTIC)		1 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	LOTION / TOPICAL	0.2 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SYRUP / ORAL	2 mg/5ml		Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / AURICULAR (OTIC)	0.2 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / OPHTHALMIC		8 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	TABLET, EXTENDED RELEASE / ORAL		350 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUPPOSITORY / RECTAL	72.15 mg		Exact identifier — unii candidate 78 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ba83b1fe-23a3-4673-8b31-e47d02cf1cd7			ca59ecb1-2a80-41f3-a0c8-816e1590c611	2010-01-04	Warnings	Exact identifier spl id: ba83b1fe-23a3-4673-8b31-e47d02cf1cd7 spl set id: ca59ecb1-2a80-41f3-a0c8-816e1590c611

Reported adverse events (FAERS/openFDA)#

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