tina davies IceCream

Manufacturer
TINA DAVIES PROFESSIONAL LLC
Effective date
2026-07-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-07-17 21:45:37

Label at a glance#

ProductTina Davies IceCream
Active ingredientLIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

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

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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 5%

Phenylephrine HCl 0.25%

Purpose

OTC - PURPOSE SECTION

Local anesthetic

Vasoconstrictor

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only
Allergy alert:
Certain persons can develop allergic reactions to ingredients in this product. 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, or 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.
• Bleeding occurs.

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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acetyl Hexapeptide-8, Butylene Glycol, Carboxymethyl Cellulose 2500, Chloroxylenol, Hexanediol CG, Pentapeptide-18, Phenoxyethanol, Ethylhexylglycerin, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Propylene Glycol, Sodium Hyaluronate, Water (Aqua).

SPL UNCLASSIFIED SECTION

2-in-1 Maximum

Strength Formula

Hemorrhoidal cream

with vasoconstrictor

and local anesthetic

Manufactured for Tina  Davies Professional LLC

1020 Holland Drive, Unit

109 Boca Raton, FL 33487

1-888-510-1388

tinadavies.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IceCreamIceCream

IceCreamIceCream

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130846667003011GTIN-13: 0846667003011
EAN-13: 0846667003011
GTIN-12: 846667003011
UPC-A: 846667003011
GTIN storage (14 digits): 00846667003011
84313001-3.jpg
QR code linkQR Codeqrcodes.pro/evtDo084313001-4.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84313-00184313-001-30, 84313-001-05, 84313-001-15

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62026-07-01weekly-update2026-07-17 21:42:14
22026-03-16full-release2026-06-01 01:52:19

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 IceCreamLIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC6a2b3199-f405-4455-9a02-8885d24eef9c2026-07-09WarningsExact identifier
ndc (package): 84313-001-05
ndc (package): 84313-001-15
ndc (package): 84313-001-30
ndc (product): 84313-001
ndc11 (package): 84313000105
ndc11 (package): 84313000115
ndc11 (package): 84313000130
spl id: 5282563a-c4f4-48d2-90ca-aac5fa7318ec
spl set id: 6a2b3199-f405-4455-9a02-8885d24eef9c

Reported adverse events (FAERS/openFDA)#

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