FDA.reportPublic FDA data

Family Wellness

Manufacturer
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Effective date
2023-10-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:57:37

Label at a glance#

ProductFamily Wellness
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure14 sections

Storage and handling

Other information - store at room temperature 59 - 86 F (15 - 30 C)

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Inactive Ingredients - cetyl alcohol, glycerol stearate,

laureth-23, methylparaben, mineral oil, petrolatum, propylene

glycol, propylparaben, stearic acid, stearyl alcohol, water

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Diphenhydramine hydrochloride 2 %

Zinc acetate 0.1 %

OTC - PURPOSE SECTION

Purpose

---Topical analgesic

---Skin protectant

INDICATIONS & USAGE SECTION

Uses  for temporary relief from pain and itching associated

with insect bites, sunburn and minor skin irritations. Dries the

oozing and weeping of poison: -ivy -oak - sumac

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

-over large areas of the body

-with any other product containing diphenhydramine,

including those taken orally

OTC - WHEN USING SECTION

When using this product - avoid contact with eyes

OTC - ASK DOCTOR SECTION

Ask a doctor before use

-on chicken pox

-on measles

OTC - STOP USE SECTION

Stop use and ask a doctor if:

-symptoms last for more than 7 days

-the condition gets worse

-symptoms clear up and then occur again within a few days

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

-for adults and children over 2 years of age: apply to affected area

not more than 3 or 4 times per day

-children under 2 years of age: ask a doctor before use

STORAGE AND HANDLING SECTION

Other information - store at room temperature 59 - 86 F (15 - 30 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
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN4
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD4
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55621-007-01Family Wellness1 in 1 BOXCREAM14
55621-007-01Family Wellness28 g in 1 TUBECREAM284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55621-007FAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20231025_fefbe351-1cd9-4a2f-a43d-51e2c4eb180b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD402
ZINC ACETATEACTIVE INGREDIENTFM5526K07A2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M2
ZINC CATIONACTIVE MOIETY13S1S8SF372
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE42
LAURETH-23INACTIVE INGREDIENTN72LMW566G2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55621-00755621-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LAURETH-23N72LMW566GIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
STEARIC ACID4ELV7Z65APIACT
STEARYL ALCOHOL2KR89I4H1YIACT
WATER059QF0KO0RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ZINC ACETATEFM5526K07AACTIM

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 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LAURETH-23LAURETH-23N72LMW566GCREAM / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GCREAM / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 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 WellnessDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEZhejiang Jingwei Pharmaceutical Co., Ltd.fefbe351-1cd9-4a2f-a43d-51e2c4eb180b2023-10-24WarningsExact identifier
ndc (package): 55621-007-01
ndc (product): 55621-007
ndc11 (package): 55621000701
spl id: 0882dc65-a451-daec-e063-6394a90a10ff
spl set id: fefbe351-1cd9-4a2f-a43d-51e2c4eb180b

Reported adverse events (FAERS/openFDA)#

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