• for temporary relief of pain, soreness and burning • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoid tissue • temporarily provides a coating for relief of anorectal discomforts • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
• : when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream. • when first opening the tube, puncture foil seal with top end of cap • apply externally or in the lower portion of the anal canal only • apply externally to the affected area up to 4 times daily, especially at night, in the ...
Phenylephrine HCl 0.25%
Pramoxine HCl 1%
Vasoconstrictor
Local anesthetic
• for temporary relief of pain, soreness and burning • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoid tissue • temporarily provides a coating for relief of anorectal discomforts • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
For external use only
this product if you have
• heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland • unless directed by a doctor.
if you are presently taking a prescription drug for high blood pressure or depression.
• do not exceed the recommended daily dosage unless directed by a doctor.
• attach the applicator to the tube. Lubricate the applicator well, then gently insert the applicator into the rectum. FOR INTRARECTAL USE:
In case of bleeding, consult a doctor promptly.
• condition worsens or does not improve within 7 days • an allergic reaction develops • the symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away.
• : when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream. • when first opening the tube, puncture foil seal with top end of cap • apply externally or in the lower portion of the anal canal only • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement Children under 12 years of age: ask a doctor.
Adults
• store at 20-25°C (68-77°F) • do not use if printed safety seal on cap is broken or missing
Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Behentrimonium Methosulfate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Cucumis Sativus (Cucumber) Extract, Decyl Glucoside, Dimethicone, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract, Hamamelis Virginiana (Witch Hazel), Isopropyl Myristate, PEG-100 Stearate, Petrolatum, Polysorbate-20, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1293856 | phenylephrine HCl 0.25 % / pramoxine HCl 1 % Rectal Cream | PSN | 2 |
| 1293856 | phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream | SCD | 2 |
| 1293856 | phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % Rectal Cream | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83311-335-00 | SIMPLE PROMISE Simple H Hemorrhoid Relief Cream | 56.7 g in 1 TUBE | CREAM | 56.7 | 2 | |
| 83311-335-00 | SIMPLE PROMISE Simple H Hemorrhoid Relief Cream | 1 in 1 BOX | CREAM | 1 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 83311-335 | SIMPLE PROMISE SIMPLE H HEMORRHOID RELIEF CREAM (PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE) CREAM [SIMPLE PROMISE PTE LTD] | 2 | Current NDC, 2 package rows | 20231106_f6622caa-3b31-9b07-e053-2a95a90a8a51.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 83311-335 | 83311-335-00 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| SIMPLE PROMISE Simple H Hemorrhoid Relief Cream | PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE | SIMPLE PROMISE PTE LTD | f6622caa-3b31-9b07-e053-2a95a90a8a51 | 2023-11-06 | Warnings | 83311-335-00 83311-335 83311033500 0976dfc5-c33b-11fe-e063-6294a90aa2bb f6622caa-3b31-9b07-e053-2a95a90a8a51 |
Adverse event summaries are temporarily unavailable. Other product information remains available.