Storage and handling
store at room temperature 68 - 77 F(20 - 25 C). Other information
store at room temperature 68 - 77 F(20 - 25 C). Other information
Active ingredients (in each gram)
Glycerin 14.4%
Phenylephrine HCL 0.25%
Pramoxine HCL 1%
White petrolatum 15%
Purpose
Protectant
Vasoconstrictor
Local anesthetic
Protectant
Uses
Warnings
For external use only.
When using this product
-do not put this product into the rectum by using fingers or any mechanical device or applicator
-do not exceed recommended daily dosage unless directed by a doctor
Ask a doctor before use if you have
-heart disease -high blood pressure -thyroid disease -diabetes
-trouble urinating due to an enlarged prostate gland
presently taking a prescription Ask a doctor or pharmacist before use if you are
drug for high blood pressure.
Stop use and ask a doctor if
-bleeding occurs -condition worsens or does not improve within 7 days.
-if the symptoms being treated do not subside or if redness, irritation, swelling,
pain or other symptoms develop or increase. Some people can develop allergic
reactions to ingredients in this product.
, ask a health professional before use. If pregnant or breast-feeding
. If swallowed, get medical help or contact a Keep out of reach of children
Poison Control Center right away.
Adults: Directions
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, especially at night or -
in the morningor after each bowel movement.
Children under 12 years of age: consult a doctor.
store at room temperature 68 - 77 F(20 - 25 C). Other information
aloe barbadensis leaf extract, Inactive ingredients
carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate,
methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80,
water, xanthan gum
| 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 |
|---|---|---|---|
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55621-012-01 | 2021-10-26 | C162847 | 48780-1 | ba0f9c33-4068-a910-e053-dadaa90a0b85 | fde9cd90-d63c-4058-b46e-511fecea36ec |
| 55621-012-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4068-a910-e053-dadaa90a0b85 | fde9cd90-d63c-4058-b46e-511fecea36ec |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55621-012-01 | Family Wellness | 26 g in 1 TUBE | CREAM | 26 | 3 | |
| 55621-012-01 | Family Wellness | 1 in 1 BOX | CREAM | 1 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55621-012 | FAMILY WELLNESS (GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231025_fde9cd90-d63c-4058-b46e-511fecea36ec.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55621-012 | 55621-012-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| PARAFFIN | I9O0E3H2ZE | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| GLYCERIN | PDC6A3C0OX | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIM |
| PRAMOXINE HYDROCHLORIDE | 88AYB867L5 | ACTIB |
| PETROLATUM | 4T6H12BN9U | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Family Wellness | GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM | Zhejiang Jingwei Pharmaceutical Co., Ltd. | fde9cd90-d63c-4058-b46e-511fecea36ec | 2023-10-24 | Warnings | 55621-012-01 55621-012 55621001201 08835b51-a1a6-985b-e063-6294a90a14c9 fde9cd90-d63c-4058-b46e-511fecea36ec |
Adverse event summaries are temporarily unavailable. Other product information remains available.