Storage and handling
Other information store at 20-25°C (68-77°F)
Astonea Hemorrhoidal Cream
- Manufacturer
- ASTONEA LABS PRIVATE LIMITED
- Effective date
- 2024-06-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:14:19
Label at a glance#
ProductHEMORRHOIDALCREAMPro
Active ingredientMINERAL OIL, PHENYLEPHRINE HYDROCHLORIDE, PETROLATUM
Label structure8 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
Mineral Oil (14% w/w)............................................. Skin Protectant
Petrolatum (74.9% w/w)........................................... Skin Protectant
Phenylephrine HCl (0.25% w/w).................. Vasoconstrictor
INDICATIONS & USAGE SECTION
Uses
- Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burning)
- Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders
WARNINGS SECTION
Warnings
For external use only
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
OTC - ASK DOCTOR/PHARMACIST SECTION
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 into the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if
- bleeding occurs
- condition worsens or does not improve within 7 days
- an allergic reaction develops
- the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
OTC - PREGNANCY OR BREAST FEEDING SECTION
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.
DOSAGE & ADMINISTRATION SECTION
Directions
- Adults: when possible, clean affected area with mild soap or warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use
- To use applicator, attach it to the tube, lubricate well, then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse applicator after use with mild soap and warm water and rinse thoroughly
- Apply externally to the affected area up to 4 times daily, especially at night, when waking up and after each bowel movement
- Children under 12 years of age: ask a doctor
STORAGE AND HANDLING SECTION
Other information
store at 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
Alpha Tocopherol (Vitamin E), Benzoic Acid, Butylated Hydroxyanisole, Corn Oil, Glycerin, Lanolin, PEG-40 Hydrogenated Castor Oil, PEG-100 Stearate, Propylene Glycol, Thymus Vulgaris (Thyme) Flower/Leaf Oil, White Wax
PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 77338-410-55 | 2024-06-25 | C162847 | 48780-1 | 1030e365-4b0d-111a-e063-dadaa90a10e2 | Astonea Hemorrhoidal Cream |
| 77338-410-55 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4b0d-111a-e063-dadaa90a10e2 | Astonea Hemorrhoidal Cream |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77338-410-55 | HEMORRHOIDALCREAMPro | 56.6 g in 1 TUBE | CREAM | 56.6 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- HEMORRHOIDALCREAMPro
- Phenylephrine HCl, Petrolatum, Mineral Oil
- POLYOXYL 100 STEARATE
- PROPYLENE GLYCOL
- WHITE WAX
- THYMUS VULGARIS LEAF
- BENZOIC ACID
- .ALPHA.-TOCOPHEROL ACETATE
- MINERAL OIL
- BUTYLATED HYDROXYANISOLE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- PETROLATUM
- CORN OIL
- GLYCERIN
- LANOLIN
- POLYOXYL 40 HYDROGENATED CASTOR OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 77338-410 | 77338-410-55 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 1bbaf306-f8dd-6054-e063-6294a90a57c3 | e9c32d81-cd9d-4ff2-e053-2995a90aa499 | 2024-06-25 | Warnings | 1bbaf306-f8dd-6054-e063-6294a90a57c3 e9c32d81-cd9d-4ff2-e053-2995a90aa499 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.