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
Ask a doctor before use if you have
•heart disease •high blood pressure •thyroid disease •diabetes
•trouble urinating due to an enlarged prostate gland
you are presently taking a prescription Ask a doctor or pharmacist before use if
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 ir 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. Gentlydry 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 r
in the morningor after each bowel movement.
hildren 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 | 6 |
| 1293649 | glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream | SCD | 6 |
| 1293649 | glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal Cream | SY | 6 |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69571-004-01 | Family Wellness | 26 g in 1 TUBE | CREAM | 26 | 6 | |
| 69571-004-02 | Family Wellness | 1 in 1 BOX | CREAM | 1 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69571-004 | 69571-004-01, 69571-004-02 |
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 HCL, PRAMOXINE HCL, PETROLATUM | FRONT PHARMACEUTICAL PLC | eb1785f4-5876-443b-b175-9b59d65d1a48 | 2023-10-26 | Warnings | 69571-004-02 69571-004-01 69571-004 69571000402 69571000401 08a17869-d45f-18ce-e063-6394a90adbbb eb1785f4-5876-443b-b175-9b59d65d1a48 |
Adverse event summaries are temporarily unavailable. Other product information remains available.