FDA.reportPublic FDA data

ItchZap

Manufacturer
Rising Pharma Holdings, Inc. | Elysium Pharmaceuticals Ltd
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:43:26

Label at a glance#

ProductItchZap
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure10 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#

Drug Facts Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 2%

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.

Do not use

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

Ask a doctor before use

  • on chicken pox
  • on measles

When using this product

  • avoid contact with eyes

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • symptoms persists for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 Information

OTHER SAFETY INFORMATION

  • store between 15°C - 25°C (59°- 77°F)
  • Lot No. & Exp Date: See box or crimp of tube

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzyl alcohol, cetyl alcohol, glyceryl monostearate SE, glyceryl stearate/PEG 100 stearate, propylene glycol, water

Questions and comments?

OTC - QUESTIONS SECTION

Call 1-844-474-7464

ItchZapTM is a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: G/25/1362

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57237-352-28

ItchZapTM 

Diphenhydramine Hydrochloride 2% & Zinc Acetate 0.1%

Anti-Itch Cream

Extra Strength

Topical Analgesic/Skin Protectant

diphenhydramine-zinc-acetatediphenhydramine-zinc-acetate

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-352-28ItchZap1 in 1 CARTONCREAM11
57237-352-28ItchZap28 g in 1 TUBECREAM281

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57237-35257237-352-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ZINC ACETATEFM5526K07AACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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
ItchZapDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATERising Pharma Holdings, Inc.245d0afb-19a8-4cfb-968b-d892b18d5f2c2025-11-06WarningsExact identifier
ndc (package): 57237-352-28
ndc (product): 57237-352
ndc11 (package): 57237035228
spl id: efed5317-cd02-4fe0-8287-f5a763dd4736
spl set id: 245d0afb-19a8-4cfb-968b-d892b18d5f2c

Reported adverse events (FAERS/openFDA)#

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