FDA.reportPublic FDA data

Quality Choice Extra Strength Itch Stopping Cream 1 oz. 94731 ZDP 2020

Manufacturer
Chain Drug Marketing Associations Inc
Effective date
2020-07-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:22:47

Label at a glance#

ProductAnti itch Topical Analgesic
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure14 sections

Storage and handling

Other information store at room temperature 20-25°C (68-77°F) protect from excessive heat (40°C/104°F), humidity, and light

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Diphenhydramine HCI 2%........................................................Topical analgesic

Zinc acetate, 0.1%.................................................................... Skin protectant

OTC - PURPOSE SECTION

Uses

  • temporarily relieves pain and itching associated with:
  • insect bites
  • minor burns
  • minor skin irritations
  • sunburn
  • minor cuts
  • scrapes
  • rashes due to poison ivy, oak, and sumac
  • 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

  • with any other product containing diphenhydramine, even one taken by mouth
  • on large areas of the body

OTC - ASK DOCTOR SECTION

Ask a doctor before use

  • on chicken pox
  • on measles

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur again within a few days

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

INDICATIONS & USAGE SECTION

Directions

  • do not use more than directed
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 20-25°C (68-77°F)
  • protect from excessive heat (40°C/104°F), humidity, and light

INACTIVE INGREDIENT SECTION

inactive ingredients

cetostearyl alcohol, glyceryl stearate/peg-100 stearate, methylparaben, propylene glycol, propylparaben, purified water

DOSAGE & ADMINISTRATION SECTION

DISTRIBUTED BY:

C.D.M.A. INC.

43157 W. 9 Mile Road

Novi, MI 48375

www.qualitychoice.com

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

94731.194731.1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN2
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD2
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY2

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
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-708-282022-01-28C16284748780-1d6a99b39-91d1-a426-e053-dadaa90af4c2Quality Choice Extra Strength Itch Stopping Cream 1 oz. 94731 ZDP 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-708-28Anti itch Topical Analgesic28 g in 1 TUBECREAM282
63868-708-28Anti itch Topical Analgesic1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-708ANTI ITCH TOPICAL ANALGESIC (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATIONS INC]2Legacy NDC, 2 package rows20200728_a2cea492-a2a6-0af8-e053-2995a90a9377.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-70863868-708-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLPARABENZ8IX2SC1OHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ZINC ACETATEFM5526K07AACTIB

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
ab752766-7bae-f4a0-e053-2995a90a6996a2cea492-a2a6-0af8-e053-2995a90a93772020-07-27WarningsExact identifier
spl id: ab752766-7bae-f4a0-e053-2995a90a6996
spl set id: a2cea492-a2a6-0af8-e053-2995a90a9377

Reported adverse events (FAERS/openFDA)#

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