tina davies IceJelly TM Hemorrhoidal Cream

Manufacturer
TINA DAVIES PROFESSIONAL LLC
Effective date
2026-06-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-15 00:32:46

Label at a glance#

Producttina davies IceJelly Hemorrhoidal
Active ingredientLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

• for the temporary relief of:    • local itching and discomfort associated with hemorrhoids    • burning    • pain    • soreness • temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders. • temporarily shrinks hemorrhoidal tissue.

Dosage and administration

• adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. • apply externally to the affected area up to 4 times daily. • children under 12 years of age: ask a doctor.

Storage and handling

• store at 20–25°C (68–77°F). • protect from light. • do not use if seal is broken or missing.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% w/v
Phenylephrine HCl 0.25% w/v

Purposes

OTC - PURPOSE SECTION

Local anesthetic
Vasoconstrictor

Uses

INDICATIONS & USAGE SECTION

• for the temporary relief of:
   • local itching and discomfort associated with hemorrhoids
   • burning
   • pain
   • soreness
• temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders.
• temporarily shrinks hemorrhoidal tissue.

Warnings

WARNINGS SECTION

For external use only

Allergy alert: certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

Ask a doctor before use if you have
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the 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 the rectum by using fingers or any mechanical device or applicator.
• in case of bleeding, consult a doctor promptly.

Stop use and ask a doctor if
• condition worsens or does not improve within 7 days.
• an allergic reaction develops.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
• 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

• store at 20–25°C (68–77°F).
• protect from light.
• do not use if seal is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red No. 33, Disodium EDTA, Glycerin, Hydroxyethylcellulose, L-Cysteine HCl, Panthenol, Phenoxyethanol, Purified Water.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-510-1388
You may also report serious side effects to this phone number.

Mon - Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

Maximum Strength Formula

with local anesthetic and vasoconstrictor

Manufactured for:
Tina Davies Professional LLC
1020 Holland Drive,
Unit 109 Boca Raton,
FL 33487

Made in United Kingdom

tinadavies.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tina davies IceJellytina davies IceJelly

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeqrcodes.pro/evtDo084313101-2.jpg

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84313-10184313-101-30, 84313-101-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
tina davies IceJelly HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC580559bf-d91f-4bb3-9c9b-b7e2cd0686fd2026-06-11WarningsExact identifier
ndc (package): 84313-101-30
ndc (package): 84313-101-15
ndc (product): 84313-101
ndc11 (package): 84313010115
ndc11 (package): 84313010130
spl id: 90fb3e2a-4b65-4bc1-99fc-4cc505e36a85
spl set id: 580559bf-d91f-4bb3-9c9b-b7e2cd0686fd

Reported adverse events (FAERS/openFDA)#

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