FDA.reportPublic FDA data

tina davies IceCream TM Hemorrhoidal Cream

Manufacturer
TINA DAVIES PROFESSIONAL LLC
Effective date
2026-06-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-07-17 21:36:02

Label at a glance#

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

Indications and uses

for the temporary relief of anorectal itching and discomfort associated with hemorrhoids for the temporary relief of pain 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: consult a doctor.

Storage and handling

store in cool, dry place away from moisture and direct light

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 anorectal itching and discomfort associated with hemorrhoids
  • for the temporary relief of pain
  • 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.

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • in case of bleeding

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: consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • store in cool, dry place away from moisture and direct light

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acetyl Hexapeptide-8, Butylene Glycol, C13-14 Isoparaffin, Carboxymethylcellulose Sodium, Chloroxylenol, Ethylhexylglycerin, 1,2-Hexanediol, Laureth-7, Pentapeptide-18, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Hyaluronate, Water (Aqua).

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

2-in-1 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

TinaDaviesIcecreamTinaDaviesIcecream

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeqrcodes.pro/evtDo084313002-2.jpg

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84313-00284313-002-15, 84313-002-30, 84313-002-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ACETYL HEXAPEPTIDE-8 AMIDEL4EL31FWILIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
CHLOROXYLENOL0F32U78V2QIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
LAURETH-7Z95S6G8201IACT
PENTAPEPTIDE-18PO4D55T1IGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HYALURONATE SODIUMYSE9PPT4THIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-06-08daily-update2026-06-12 05:10:15

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 IceCream HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd2026-06-24WarningsExact identifier
ndc (package): 84313-002-15
ndc (package): 84313-002-05
ndc (package): 84313-002-30
ndc (product): 84313-002
ndc11 (package): 84313000215
ndc11 (package): 84313000230
ndc11 (package): 84313000205
spl id: dbbab694-0566-4fb8-89ad-d60b6a61e187
spl set id: 10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd

Reported adverse events (FAERS/openFDA)#

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