Helps relieve the local itching and discomfort associated with hemorrhoids Temporarily shrinks hemorrhoidal tissue and relieves burning Temporarily provides a coating for relief of anorectal discomforts Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
Adults: When practical, clean the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream. When first opening 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...
www.qualitychoice.comGlycerol 14.4%
Protectant
Phenylephrine HCI 0.25%
Vasoconstrictor
Pramoxine HCI 1%
Local Anesthetic
Petrolatum 15%
Protectant
Helps relieve the local itching and discomfort associated with hemorrhoids
Temporarily shrinks hemorrhoidal tissue and relieves burning
Temporarily provides a coating for relief of anorectal discomforts
Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
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
Ask doctor before use
If swallowed get medical help or contact a Poison Control Center right away
Adults:
When practical, clean the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream.
When first opening 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
For External Use Only
Ask doctor brfore use if you have
Heart Disease
Thyroid Disease
Diabetes
Difficulty urinating due to an enlarged prostate gland
Ask doctor before use if you are presently taking a prescription 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
Store at room temperature 20º-25ºC (68º-77ºF)
This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H®
Aloe barbadensis leaf juice, carboxmethylcellulose sodium, cetyl alcohol, glyceryl monostearate, methylparaben, mineral oil, polysorbate 80, propylene glycol, propylparaben, purified water, stearic acid, xanthan gum
Call 1-800-935-2362
C.D.M.A., Inc.®
43157 W 9 Mile Rd.
Novi, MI.48375, USA
1-00-935-2362
Product of PRC
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1293649 | glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal Cream | PSN | 3 |
| 1293649 | glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream | SCD | 3 |
| 1293649 | glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal Cream | SY | 3 |
| Class | Version | Type | Effective |
|---|---|---|---|
| GLYCERIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 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 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63868-561-09 | 2025-01-30 | C162847 | 48780-1 | ba0f9c33-1d48-a910-e053-dadaa90a0b85 | Hemorrhoidal Cream With Aloe |
| 63868-561-09 | 2023-05-23 | C162847 | 48780-1 | ba0f9c33-1d48-a910-e053-dadaa90a0b85 | Hemorrhoidal Cream With Aloe |
| 63868-561-09 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1d48-a910-e053-dadaa90a0b85 | Hemorrhoidal Cream With Aloe |
| 63868-561-09 | 2021-02-10 | C162847 | 48780-1 | ba0f9c33-1d48-a910-e053-dadaa90a0b85 | Hemorrhoidal Cream With Aloe |
| 63868-561-09 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1d48-a910-e053-dadaa90a0b85 | Hemorrhoidal Cream With Aloe |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63868-561-09 | Hemorrhoidal Cream with Aloe | 25.5 g in 1 TUBE | CREAM | 25.5 | 3 | |
| 63868-561-09 | Hemorrhoidal Cream with Aloe | 1 in 1 BOX | CREAM | 1 | 3 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63868-561-09 | GM - Gram | 63868-561 | fb065706-7600-45ae-8c20-90797a40bffa | 1 | 2021-08-05 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63868-561 | 63868-561-09 |
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 |
|---|---|---|---|---|---|---|
| fc6152a2-7161-250f-e053-6394a90a951a | 8d1e7ebe-b702-2343-e053-2995a90ac66a | 2023-05-23 | Warnings | fc6152a2-7161-250f-e053-6394a90a951a 8d1e7ebe-b702-2343-e053-2995a90ac66a |
Adverse event summaries are temporarily unavailable. Other product information remains available.