Family Wellness

Manufacturer
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Effective date
2023-10-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:57:37

Label at a glance#

ProductFamily Wellness
Active ingredientGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM
Label structure9 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each gram)

Glycerin 14.4%

Phenylephrine HCL 0.25%

Pramoxine HCL  1%

White petrolatum  15%

OTC - PURPOSE SECTION

Purpose

Protectant

Vasoconstrictor

Local anesthetic

Protectant

INDICATIONS & USAGE SECTION

Uses

  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • 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 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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.

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

  aloe barbadensis leaf extract, Inactive ingredients

carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate,

methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80,

water, xanthan gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1293649glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal CreamPSN3
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD3
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55621-012-012021-10-26C16284748780-1ba0f9c33-4068-a910-e053-dadaa90a0b85fde9cd90-d63c-4058-b46e-511fecea36ec
55621-012-012021-01-29C16284748780-1ba0f9c33-4068-a910-e053-dadaa90a0b85fde9cd90-d63c-4058-b46e-511fecea36ec

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55621-012-01Family Wellness26 g in 1 TUBECREAM263
55621-012-01Family Wellness1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55621-012FAMILY WELLNESS (GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]3Current NDC, Legacy NDC, 2 package rows20231025_fde9cd90-d63c-4058-b46e-511fecea36ec.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55621-01255621-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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 WellnessGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUMZhejiang Jingwei Pharmaceutical Co., Ltd.fde9cd90-d63c-4058-b46e-511fecea36ec2023-10-24WarningsExact identifier
ndc (package): 55621-012-01
ndc (product): 55621-012
ndc11 (package): 55621001201
spl id: 08835b51-a1a6-985b-e063-6294a90a14c9
spl set id: fde9cd90-d63c-4058-b46e-511fecea36ec

Reported adverse events (FAERS/openFDA)#

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