FDA.reportPublic FDA data

Harris Teeter Anti-Itch

Manufacturer
Harris Teeter
Effective date
2017-04-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:38

Label at a glance#

ProductHarris Teeter Anti-Itch
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure13 sections

Storage and handling

Other information store at 20° to 25°C (68° to 77°F) lot no. & exp. date: see box or see crimp of tube

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                            Purpose

Diphenhydramine hydrochloride 2%.........Topical analgesic

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

OTC - PURPOSE SECTION

Uses

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

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use

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

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 eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • conditions 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 - 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 20° to 25°C (68° to 77°F)
  • lot no. & exp. date: see box or see crimp of tube

INACTIVE INGREDIENT SECTION

Inactive ingredients

cetyl alcohol, methylparaben, polyoxyl 40 stearate, propylene glycol, propylparaben, stearyl alcohol, water

DOSAGE & ADMINISTRATION SECTION

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC

MATTHEWS, NC 28105

MADE IN KOREA

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 CreamPSN1
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD1
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY1

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
72036-402-282022-01-28C16284748780-1d6a99b39-9c5b-a426-e053-dadaa90af4c24639894a-c865-41e0-8e2a-b4851b474bc7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72036-402-28Harris Teeter Anti-Itch28 g in 1 TUBECREAM281
72036-402-28Harris Teeter Anti-Itch1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72036-402HARRIS TEETER ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATE) CREAM [HARRIS TEETER]1Legacy NDC, 2 package rows20170422_4639894a-c865-41e0-8e2a-b4851b474bc7.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72036-40272036-402-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ZINC ACETATEFM5526K07AACTIB
CETYL ALCOHOL936JST6JCNIACT
METHYLPARABENA2I8C7HI9TIACT
POLYOXYL 40 STEARATE13A4J4NH9IIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
STEARYL ALCOHOL2KR89I4H1YIACT
WATER059QF0KO0RIACT

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
926407d4-32c1-4de7-85fc-85076a247ec34639894a-c865-41e0-8e2a-b4851b474bc72017-04-21WarningsExact identifier
spl id: 926407d4-32c1-4de7-85fc-85076a247ec3
spl set id: 4639894a-c865-41e0-8e2a-b4851b474bc7

Reported adverse events (FAERS/openFDA)#

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