FDA.reportPublic FDA data

Anti-Itch

Manufacturer
Quality Choice | 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 22:56:33

Label at a glance#

ProductAnti-Itch
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure11 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, rinse with water to remove
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

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-130635515987531GTIN-13: 0635515987531
EAN-13: 0635515987531
GTIN-12: 635515987531
UPC-A: 635515987531
GTIN storage (14 digits): 00635515987531		label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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
63868-785-032020-01-31C16284748780-19d75b9d0-62e3-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-785-03Anti-Itch85 g in 1 CANSPRAY851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-785ANTI-ITCH (DIPHENHYDRAMINE HCI, ZINC ACETATE) SPRAY [QUALITY CHOICE]1Legacy NDC, 1 package rows20180808_f9018c4b-c6f2-48ea-9ba7-e518c94c0a59.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
63868-78563868-785-03

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
1f366dc9-de28-455c-97cd-8e750eb60365f9018c4b-c6f2-48ea-9ba7-e518c94c0a592018-08-08WarningsExact identifier
spl id: 1f366dc9-de28-455c-97cd-8e750eb60365
spl set id: f9018c4b-c6f2-48ea-9ba7-e518c94c0a59

Reported adverse events (FAERS/openFDA)#

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