FDA.reportPublic FDA data

Cooling Gel - NeilMed Pharmaceuticals Inc. | NeilMed Pharmaceuticals Inc

Manufacturer
NeilMed Pharmaceuticals Inc. | NeilMed Pharmaceuticals Inc
Effective date
2026-02-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:51:42

Label at a glance#

ProductCooling Gel
Active ingredientWITCH HAZEL, PHENYLEPHRINE
Label structure17 sections

Indications and uses

• helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoidal tissue • provides temporary relief from irritation and burning • temporarily provides a cooling coating for relief of anorectal discomforts

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 cream When fi rst opening the tube, puncture foil seal with top end of cap Apply externally to the affected area up to 4 times daily Children under 12 years of age: ask a doctor

Storage and handling

Storage temperature: not to exceed 30°C (86°F). Protect from freezing.

Label contents#

Full prescribing information#

Drug Facts Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCl 0.25%
Witch Hazel 50%

Purpose

OTC - PURPOSE SECTION

Phenylephrine HCl 0.25% .......................................................................Vasoconstrictor
Witch Hazel 50%. ............................................................................................Astringent

Uses

INDICATIONS & USAGE SECTION


• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily shrinks hemorrhoidal tissue • provides temporary relief from irritation
and burning • temporarily provides a cooling coating for relief of anorectal discomforts

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Difficulty in urination due to enlargement of prostate gland unless directed by a doctor

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 in the rectum by using fi ngers or any mechanical device or applicator
  • in case of bleeding, consult a doctor promptly.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Bleeding occurs

  • Condition worsens or does not improve within 7 days.

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. (1-800-222-1222)

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 cream
  • When fi rst opening the tube, puncture foil seal with top end of cap
  • Apply externally to the affected area up to 4 times daily
  • Children under 12 years of age: ask a doctor

Other information:

STORAGE AND HANDLING SECTION

Storage temperature: not to exceed 30°C (86°F).
Protect from freezing.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Edetate Disodium, Hydroxyethyl Cellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purifi ed Water, Sodium Citrate, Sulisobenzone, Vitamin E Acetate.

Questions or comments?

OTC - QUESTIONS SECTION

1 (877) 477-8633

TAMPER EVIDENT:

OTHER SAFETY INFORMATION

DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Important:

SAFE HANDLING WARNING SECTION

Please do not discard this printed box and any enclosed printed material. The inside fi nal product may not have all the details you require for the ongoing use of the product.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTubeBoxBox

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130705928150072GTIN-13: 0705928150072
EAN-13: 0705928150072
GTIN-12: 705928150072
UPC-A: 705928150072
GTIN storage (14 digits): 00705928150072		PK-IC121-Rev1-CoolingGel_1oz-BOX-V2_page-0001.jpg
QR code linkQR Codeshopnmdl.neilmed.com/products/neilmed-hemorrhoidal-pain-relief-cooling-gelPK-IC121-Rev1-CoolingGel_1oz-BOX-V2_page-0001.jpg

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-354-01Cooling Gel25.5 g in 1 TUBEGEL25.51
13709-354-01Cooling Gel1 in 1 CARTONGEL11

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-35413709-354-01

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
NameUNIIKind
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5IACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
SULISOBENZONE1W6L629B4KIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WITCH HAZEL101I4J0U34ACTIB
EDETATE DISODIUM7FLD91C86KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CITRATE1Q73Q2JULRIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
PHENYLEPHRINE1WS297W6MVACTIB

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
Cooling GelPAIN RELIEF COOLING GELNeilMed Pharmaceuticals Inc.49fb637b-ecc5-1f9b-e063-6294a90ab41a2026-02-04WarningsExact identifier
ndc (package): 13709-354-01
ndc (product): 13709-354
ndc11 (package): 13709035401
spl id: 49fb637b-ecc6-1f9b-e063-6294a90ab41a
spl set id: 49fb637b-ecc5-1f9b-e063-6294a90ab41a

Reported adverse events (FAERS/openFDA)#

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