Family wellness
- Manufacturer
- FRONT PHARMACEUTICAL PLC
- Effective date
- 2023-10-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:58:06
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each gram)
Mineral oil 14%
Petrolatum 74.9%
Phenylephrine HCl 0.25%
OTC - PURPOSE SECTION
Purposes
Protectant
Protectant
Vasoconstrictor
INDICATIONS & USAGE SECTION
•helps relieve the local itching and discomfort associated with hemorrhoids. Uses
•Temporarily shrinks hemorrhoid tissue and relieves burning.
•Temporarily provides a coating for relief of anorectal burning.
•Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less
painful
WARNINGS SECTION
Warnings
For external and/or intrarectal use only
Ask a doctor before use if you have
•heart disease •high blood pressure •thyroid disease •diabetes •trouble urinating due to
an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure.
Stop use and ask a doctor if
•bleeding occurs •condition worsens or does not improve within 7 days.
•introduction of the applicator into the rectum causes additional pain.
, ask a health professional before use. If pregnant or breast-feeding
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If swallowed, get medical help or contact a Poison Control Center right Keep out of reach of children.
away.
DOSAGE & ADMINISTRATION SECTION
Directions
Adults and children 12 years of age and older for topical use:
•clean the affected area, and pat or dab dry before applying ointment.
•apply to the affected area up to 4 times daily, especially after each bowel movement.
For intrarectal use:
•attach included applicator to tube.
•lubricate applicator tip and gently insert into rectum
•thoroughly clean applicator after each use, and replace cover
Children under 12 years of age: ask a doctor before use.
OTHER SAFETY INFORMATION
store at room temperature 68° - 77° F (20°-25° C). Other information
INACTIVE INGREDIENT SECTION
beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23, Inactive ingredients
methylparaben, propylparaben, stearyl alcohol
OTC - QUESTIONS SECTION
1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1372298 | mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal Ointment | PSN | 3 |
| 1372298 | mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment | SCD | 3 |
| 1372298 | mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment | SY | 3 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69571-006-01 | Family wellness | 57 g in 1 TUBE | OINTMENT | 57 | 3 | |
| 69571-006-02 | Family wellness | 1 in 1 BOX | OINTMENT | 1 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Family wellness
- Mineral oil, Petrolatum, Phenylephrine HCl
- YELLOW WAX
- BENZOIC ACID
- CETYL ALCOHOL
- GLYCERIN
- LAURETH-23
- METHYLPARABEN
- PROPYLPARABEN
- STEARYL ALCOHOL
- MINERAL OIL
- PETROLATUM
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69571-006 | 69571-006-01, 69571-006-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| YELLOW WAX | 2ZA36H0S2V | IACT |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| LAURETH-23 | N72LMW566G | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| MINERAL OIL | T5L8T28FGP | ACTIB |
| PETROLATUM | 4T6H12BN9U | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIM |
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 |
|---|---|---|---|---|---|---|
| Family wellness | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | FRONT PHARMACEUTICAL PLC | cfdd61e3-e12e-491c-b2a8-90fae19e8870 | 2023-10-27 | Warnings | 69571-006-02 69571-006-01 69571-006 69571000602 69571000601 08ad6b35-733b-c9d3-e063-6294a90acfed cfdd61e3-e12e-491c-b2a8-90fae19e8870 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
