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#

ProductFamily wellness
Active ingredientMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

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

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN3
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD3
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69571-006-01Family wellness57 g in 1 TUBEOINTMENT573
69571-006-02Family wellness1 in 1 BOXOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69571-006FAMILY WELLNESS (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [FRONT PHARMACEUTICAL PLC]3Current NDC, Legacy NDC, 2 package rows20231027_cfdd61e3-e12e-491c-b2a8-90fae19e8870.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69571-00669571-006-01, 69571-006-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family wellnessMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLFRONT PHARMACEUTICAL PLCcfdd61e3-e12e-491c-b2a8-90fae19e88702023-10-27WarningsExact identifier
ndc (package): 69571-006-02
ndc (package): 69571-006-01
ndc (product): 69571-006
ndc11 (package): 69571000602
ndc11 (package): 69571000601
spl id: 08ad6b35-733b-c9d3-e063-6294a90acfed
spl set id: cfdd61e3-e12e-491c-b2a8-90fae19e8870

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.