FDA.reportPublic FDA data

Extra Strength First Aid Anti-itch

Manufacturer
Rite Aid | Product Quest Mfg
Effective date
2018-05-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:35

Label at a glance#

ProductExtra Strength First Aid Anti-itch Rite Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE ANHYDROUS
Label structure6 sections

Indications and uses

temporarily relieves itching and pain associated with minor irritations, burns, scrapes, cuts, insect bites and rashes due to poison oak & poison sumac. Dries the oozing and weeping of poison ivy, poison oak & poison sumac.

Label contents#

Full prescribing information#

Active ingredients                          Purpose

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl – 2%           Topical analgesic
Zinc Acetate – 0.1%                        Skin Protectant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves itching and pain associated with minor irritations, burns, scrapes, cuts, insect bites and rashes due to poison oak & poison sumac. Dries the oozing and weeping of poison ivy, poison oak & poison sumac.

WarningsFor external use only.Flammable. Keep away from fire or flame.

WARNINGS SECTION

OTC - DO NOT USE SECTION

​Do not use • with any other product containing Diphenhydramine, even onetaken by mouth • on large areas of the body

Ask a doctor before use

OTC - ASK DOCTOR SECTION

• on chicken pox

• on measles

OTC - WHEN USING SECTION

​When using this product​ • avoid contact with eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if
• condition worsens or does not improve within 7 days
• symptoms persist more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

Other information

OTHER SAFETY INFORMATION

Store at 20​o​ - 25​o​C (68​o​ - 77​o​F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Glycerin, Povidone, Purified Water, Tromethamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage 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-130011822928120GTIN-13: 0011822928120
EAN-13: 0011822928120
GTIN-12: 011822928120
UPC-A: 011822928120
GTIN storage (14 digits): 00011822928120		back.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
11822-7796-22020-01-31C16284748780-19d75b9d0-7eee-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-7796-2Extra Strength First Aid Anti-itchRite Aid59 mL in 1 BOTTLESPRAY591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-7796EXTRA STRENGTH FIRST AID ANTI-ITCH RITE AID (DIPHENHYDRAMINE HCL 2% ZINC ACETATE 0.1%) SPRAY [RITE AID]1Legacy NDC, 1 package rows20180518_ac3ddbce-e2e2-4e32-ba19-ae080bf8d416.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
11822-779611822-7796-2

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 ACETATE ANHYDROUSH2ZEY72PMEACTIM
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
b9b1f566-ab1a-442b-b79f-5543f99927e5ac3ddbce-e2e2-4e32-ba19-ae080bf8d4162018-05-18WarningsExact identifier
spl id: b9b1f566-ab1a-442b-b79f-5543f99927e5
spl set id: ac3ddbce-e2e2-4e32-ba19-ae080bf8d416

Reported adverse events (FAERS/openFDA)#

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