FDA.reportPublic FDA data

Itch Relief

Manufacturer
Care One | Product Quest Mfg, LLC
Effective date
2018-08-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:32

Label at a glance#

ProductItch Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure12 sections

Indications and uses

Temporarily relieves pain and itching associated with: insect bites minor burns sunburn minor cuts scrapes minor skin irritations rashes due to poison ivy, oak and sumac dries the oozing and weeping of poison ivy, oak and sumac

Dosage and administration

shake well 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 to apply to face, spray into palm of hand and gently apply

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 2.0%

Zinc Acetate 0.10%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Skin protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching associated with:

  • insect bites
  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • minor skin irritations
  • rashes due to poison ivy, oak and sumac
  • dries the oozing and weeping of poison ivy, oak and sumac

Warnings

WARNINGS SECTION

For external use only.

Flammable - Do not use while smoking or near heat or flame ​​​​

Do not use

OTC - DO NOT USE SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days
  • symptoms clear up and occur again in a few days

OTC - WHEN USING SECTION

When using this product

keep out of eyes
use only as directed.
do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well
  • 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
  • to apply to face, spray into palm of hand and gently apply

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat.
Glycerin
PVP
Tromethamine
Water

OTHER SAFETY INFORMATION

Other information Store at 20° to 25°C (68° to 77°F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053138diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SprayPSN1
1053138diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SpraySCD1
1053138diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SpraySY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130341520001505GTIN-13: 0341520001505
EAN-13: 0341520001505
GTIN-12: 341520001505
UPC-A: 341520001505
GTIN storage (14 digits): 00341520001505		label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
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
41520-350-032020-01-31C16284748780-19d75b9cf-df94-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-350-03Itch Relief85 g in 1 CANSPRAY851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-350ITCH RELIEF (DIPHENHYDRAMINE HCI, ZINC ACETATE) SPRAY [CARE ONE]1Legacy NDC, 1 package rows20180808_7a44fceb-ef28-423e-9f9a-8ea512697550.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-35041520-350-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ZINC ACETATEFM5526K07AACTIM
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
POVIDONEFZ989GH94EIACT
WATER059QF0KO0RIACT
TROMETHAMINE023C2WHX2VIACT

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
687657f8-a35c-4399-bc58-6341ca2c96a17a44fceb-ef28-423e-9f9a-8ea5126975502018-08-08WarningsExact identifier
spl id: 687657f8-a35c-4399-bc58-6341ca2c96a1
spl set id: 7a44fceb-ef28-423e-9f9a-8ea512697550

Reported adverse events (FAERS/openFDA)#

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