FDA.reportPublic FDA data

Family Wellness

Manufacturer
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Effective date
2023-10-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:57:35

Label at a glance#

ProductFamily Wellness
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM
Label structure14 sections

Storage and handling

Other information - store at room temperature 68 - 77 F (20 - 25 C).

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Inactive Ingredients - beeswax, benzoic acid, cetyl alcohol, glycerin,

laureth - 23, methylparaben, propylparaben, stearyl alcohol

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each gram)

Mineral oil 14 %

Petrolatum 74.9 %

Phenylephrine HCI  0,25 %

OTC - PURPOSE SECTION

Purposes

--- Protectant

---Protectant

---Vasoconstrictor

INDICATIONS & USAGE SECTION

Uses - Helps relieve the local itching and discomfort associated with hemorrhoids.

-Temporarily shrinks hemorrhoid 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

WARNINGS SECTION

Warnings

For external and/or intrarectal use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

- heart disease

-high blood pressure

-thyroid disease

-diabetes

-trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug due to high blood pressure

OTC - STOP USE SECTION

Stop use and ask a doctor if

-bleeding occurs

-condition worsens or does not improve within 7 days.

-Introduction of the appllicator into the rectum causes additional pain

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center

right 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.

STORAGE AND HANDLING SECTION

Other information - store at room temperature 68 - 77 F (20 - 25 C).

OTC - QUESTIONS SECTION

Questions? - 1-800-639-3803  Weekdays 9 AM to 4 PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

copy of labelcopy of label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN4
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD4
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55621-006-01Family Wellness1 in 1 BOXOINTMENT14
55621-006-01Family Wellness57 g in 1 TUBEOINTMENT574

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55621-006FAMILY WELLNESS (PHENYLEPHRINE HCL, PETROLATUM, MINERAL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20231025_bfa195d7-d87f-43b5-bbf1-7ec3a451de05.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGP1
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
MINERAL OILACTIVE MOIETYT5L8T28FGP1
PETROLATUMACTIVE MOIETY4T6H12BN9U1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
LAURETH-23INACTIVE INGREDIENTN72LMW566G1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V1

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
55621-00655621-006-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
BENZOIC ACID8SKN0B0MIMIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
LAURETH-23N72LMW566GIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
STEARYL ALCOHOL2KR89I4H1YIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
MINERAL OILT5L8T28FGPACTIB
PETROLATUM4T6H12BN9UACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii+route
14 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route
14 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GLOTION / TOPICAL0.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii+route
14 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / RECTAL11 mgExact identifier — unii+route
14 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSUSPENSION / RECTAL0.1 %w/wExact identifier — unii+route
14 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / RECTAL11 mgExact identifier — unii+route
14 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route
14 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GEMULSION / TOPICAL0.45 %w/wExact identifier — unii+route
10 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GCREAM / TOPICAL0.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GEMULSION / TOPICAL0.45 %w/wExact identifier — unii+route
10 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii+route
14 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YOINTMENT / TOPICAL569 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GAEROSOL, FOAM / TOPICAL1.08 %w/wExact identifier — unii+route
10 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMLOTION / TOPICAL0.2 %w/wExact identifier — unii+route
14 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GLOTION / TOPICAL0.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GAEROSOL / TOPICAL0.45 %w/wExact identifier — unii+route
10 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GCREAM / TOPICAL0.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GAEROSOL, FOAM / TOPICAL1.08 %w/wExact identifier — unii+route
10 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GAEROSOL / TOPICAL0.45 %w/wExact identifier — unii+route
10 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YOINTMENT / TOPICAL569 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSUSPENSION / RECTAL0.1 %w/wExact identifier — unii+route
14 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / TOPICAL0.1 %w/wExact identifier — unii+route
14 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / TOPICAL0.1 %w/wExact identifier — unii+route
14 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii+route
14 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMLOTION / TOPICAL0.2 %w/wExact identifier — unii+route
14 equally ranked IID candidates

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 WellnessPHENYLEPHRINE HCL, PETROLATUM, MINERALZhejiang Jingwei Pharmaceutical Co., Ltd.bfa195d7-d87f-43b5-bbf1-7ec3a451de052023-10-25WarningsExact identifier
ndc (package): 55621-006-01
ndc (product): 55621-006
ndc11 (package): 55621000601
spl id: 08846c1b-91cd-aadf-e063-6294a90accfa
spl set id: bfa195d7-d87f-43b5-bbf1-7ec3a451de05

Reported adverse events (FAERS/openFDA)#

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