FDA.reportPublic FDA data

Family Wellness

Manufacturer
Zhejiang Jingwei Pharmaceutic Al Co., Ltd.
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:07

Label at a glance#

ProductFamily Wellness
Active ingredientBENZOCAINE, RESORCINOL
Label structure9 sections

Storage and handling

Other information Atore at 20° -  25°  C (68° -  77° F).

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Benzocaine  20%

Resorcinol  3%

OTC - PURPOSE SECTION

Purpose

External Analgesic

External Analgesic

INDICATIONS & USAGE SECTION

temporarily relieves itching Uses

WARNINGS SECTION

. Warnings For external use only

avoid contact When using this product

with the eyes.

if condition Stop use and ask a doctor

worsens, or if symptoms persists for

more than 7 days or clear up and occur

again within a few days.

over large areas of the body. Do not apply

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

. If Keep out of reach of children

swallowed, get medical help or contact

a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

• Adults and children 12 years and older:

apply a fingertip amount (approximately

1 inch strip) to the affected area not

more than 3 to 4 times daily.

•: ask a doctor Children udner 12 years

STORAGE AND HANDLING SECTION

Other information

Atore at 20° -  25°  C (68° -  77° F).

INACTIVE INGREDIENT SECTION

Inactive ingredients

Aloe barbadensis leaf juice,

Cetyl alcohol, Cholecalciferol,

EDTA, Fragrance, Glyceryl

stearate, Isopropyl myristate,

Isopropyl palmitate, Lanolin,

Methylparaben, Mineral Oil,

Petrolatum, Propylene glycol,

Retinol, Sodium lauryl sulfate,

Sodium Sulfate, Tocopherol,

Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
637518benzocaine 20 % / resorcinol 3 % Vaginal CreamPSN2
637518benzocaine 200 MG/ML / resorcinol 30 MG/ML Vaginal CreamSCD2
637518benzocaine 20 % / resorcinol 3 % Vaginal CreamSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55621-016-01Family Wellness1 in 1 CARTONCREAM12
55621-016-01Family Wellness28 g in 1 TUBECREAM282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55621-016FAMILY WELLNESS (BENZOCAINE, RESORCINOL) CREAM [ZHEJIANG JINGWEI PHARMACEUTIC AL CO., LTD.]2Current NDC, Legacy NDC, 2 package rows20231027_df540eb8-6773-4647-9cc2-c3fd14d7355e.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55621-01655621-016-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL PALMITATE8CRQ2TH63MIACT
LANOLIN7EV65EAW6HIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
RETINOLG2SH0XKK91IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM SULFATE0YPR65R21JIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
BENZOCAINEU3RSY48JW5ACTIB
RESORCINOLYUL4LO94HKACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CETYL ALCOHOL936JST6JCNIACT
CHOLECALCIFEROL1C6V77QF41IACT
EDETIC ACID9G34HU7RV0IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT

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 WellnessBENZOCAINE, RESORCINOLZhejiang Jingwei Pharmaceutic Al Co., Ltd.df540eb8-6773-4647-9cc2-c3fd14d7355e2023-10-27WarningsExact identifier
ndc (package): 55621-016-01
ndc (product): 55621-016
ndc11 (package): 55621001601
spl id: 08ad56e9-b3d4-3128-e063-6394a90ab417
spl set id: df540eb8-6773-4647-9cc2-c3fd14d7355e

Reported adverse events (FAERS/openFDA)#

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