FDA.reportPublic FDA data

ANTI-ITCH

Manufacturer
OL PHARMA TECH, LLC | OL PHARMA TECH, LLC Drs PHARMACY
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:52:14

Label at a glance#

ProductANTI-ITCH
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure15 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 1%

Zinc Acetate 0.1%

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 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

WARNINGS SECTION

For external use only

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • on chicken pox
  • on measles

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

When using this product

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 - 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.

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 SAFETY INFORMATION

protect from excessive heat (40°C/104°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E

Questions

OTC - QUESTIONS SECTION

drspharmacyusa.com

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anti itch creamAnti itch cream

Itch stopping cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1292313diphenhydrAMINE HCl 1 % / zinc acetate 0.1 % Topical CreamPSN4
1292313diphenhydramine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD4
1292313diphenhydramine hydrochloride 1 % / zinc acetate 0.1 % Topical CreamSY4

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80489-005-01ANTI-ITCH28.3 g in 1 TUBECREAM28.34
80489-005-01ANTI-ITCH1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80489-005ANTI-ITCH (ZINC ACETATE , DIPHENHYDRAMINE) CREAM [OL PHARMA TECH, LLC]4Current NDC, Legacy NDC, 2 package rows20250112_b79d3096-c609-e710-e053-2995a90a8da2.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80489-00580489-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
DECYL OLEATEZGR06DO97TIACT
TROLAMINE9O3K93S3TKIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ZINC ACETATEFM5526K07AACTIM
MINERAL OILT5L8T28FGPIACT
SODIUM CETOSTEARYL SULFATE7ZBS06BH4BIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT

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
ANTI-ITCHZINC ACETATE , DIPHENHYDRAMINEOL PHARMA TECH, LLCb79d3096-c609-e710-e053-2995a90a8da22025-01-09WarningsExact identifier
ndc (package): 80489-005-01
ndc (product): 80489-005
ndc11 (package): 80489000501
spl id: 2b51fa9d-b2ae-c4bf-e063-6294a90a3105
spl set id: b79d3096-c609-e710-e053-2995a90a8da2