Family Wellness Anti-Itch Cream, 28g

Manufacturer
FRONT PHARMACEUTICAL PLC
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:58:10

Label at a glance#

ProductFamily Wellness
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

OTC - PURPOSE SECTION

Purpose

Topical analgesic

Skin protectant

INDICATIONS & USAGE SECTION

for temprary relief from pain and itching associated Uses

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

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

WARNINGS SECTION

Warnings

. For external use only

Do not use

•avoid contact with eyes When using this product

Ask a doctor before use

•on chicken pox  •on measles

Stop use and ask a doctor if

  • over large areas of the body
  • with any other product containing diphenhydramine including those taken orally
  • 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

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

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 to 4 times daily

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

OTHER SAFETY INFORMATION

store at room temperature 59° - 86° F Other information

(15° - 30° C).

INACTIVE INGREDIENT SECTION

cetyl alcohol, glyceryl stearate se, Inactive ingredients

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

glycol, propylparaben, stearic acid, stearic alcohol, water

OTC - QUESTIONS SECTION

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

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
69571-005-01Family Wellness28 g in 1 TUBECREAM284
69571-005-02Family Wellness1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69571-005FAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [FRONT PHARMACEUTICAL PLC]4Current NDC, Legacy NDC, 2 package rows20231027_fde2069b-344e-46da-bb95-c5113e0f35d6.zip

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
69571-00569571-005-01, 69571-005-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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 WellnessDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEFRONT PHARMACEUTICAL PLCfde2069b-344e-46da-bb95-c5113e0f35d62023-10-26WarningsExact identifier
ndc (package): 69571-005-01
ndc (package): 69571-005-02
ndc (product): 69571-005
ndc11 (package): 69571000501
ndc11 (package): 69571000502
spl id: 08a16eed-ba21-b1fa-e063-6294a90a6615
spl set id: fde2069b-344e-46da-bb95-c5113e0f35d6

Reported adverse events (FAERS/openFDA)#

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