Indications and uses
• For the temporary relief of anorectal itching and discomfort associated with hemorrhoids. • For temporary relief of pain.
• For the temporary relief of anorectal itching and discomfort associated with hemorrhoids. • For temporary relief of pain.
• 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.
Lidocaine HCl 5%
Phenylephrine HCl 0.25%
Local anesthetic
Vasoconstrictor
• For the temporary relief of anorectal itching and discomfort associated with hemorrhoids.
• For temporary relief of pain.
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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
• 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.
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).
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
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0846667003011 | GTIN-13: 0846667003011 EAN-13: 0846667003011 GTIN-12: 846667003011 UPC-A: 846667003011 GTIN storage (14 digits): 00846667003011 | 84313001-3.jpg |
| QR code link | QR Code | 84313001-4.jpg |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 84313-001-05 | 2026-01-29 | C162847 | 48780-1 | 49896155-c60e-586f-e063-e6dba90add90 | tina davies IceCream |
| 84313-001-05 | 2026-01-29 | C162847 | 48780-1 | 49896155-c60e-586f-e063-e6dba90add90 | tina davies IceCream |
| 84313-001-05 | 2026-01-29 | C162847 | 48780-1 | 49896155-c60e-586f-e063-e6dba90add90 | tina davies IceCream |
| 84313-001-30 | 2026-01-29 | C162847 | 48780-1 | 49896155-c60e-586f-e063-e6dba90add90 | tina davies IceCream |
| 84313-001-30 | 2026-01-29 | C162847 | 48780-1 | 49896155-c60e-586f-e063-e6dba90add90 | tina davies IceCream |
| 84313-001-30 | 2026-01-29 | C162847 | 48780-1 | 49896155-c60e-586f-e063-e6dba90add90 | tina davies IceCream |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 84313-001 | 84313-001-30, 84313-001-05, 84313-001-15 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 6 | 2026-07-01 | weekly-update | 2026-07-17 21:42:14 |
| 2 | 2026-03-16 | full-release | 2026-06-01 01:52:19 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tina Davies IceCream | LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE | TINA DAVIES PROFESSIONAL LLC | 6a2b3199-f405-4455-9a02-8885d24eef9c | 2026-07-09 | Warnings | 84313-001-05 84313-001-15 84313-001-30 84313-001 84313000105 84313000115 84313000130 5282563a-c4f4-48d2-90ca-aac5fa7318ec 6a2b3199-f405-4455-9a02-8885d24eef9c |
Adverse event summaries are temporarily unavailable. Other product information remains available.