FDA.reportPublic FDA data

Anti-Itch Cream

Manufacturer
Kroger | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-11-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:16:03

Label at a glance#

ProductAnti-Itch Cream
Active ingredientZINC ACETATE, DIPHENHYDRAMINE HYDROCHLORIDE
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

SPL UNCLASSIFIED SECTION

-

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

OTC - DO NOT USE SECTION

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

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • on chicken pox
  • on measles

When using this product

OTC - WHEN USING SECTION

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

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 (1-800-222-1222).

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° - 25°C (68°-77°F)
  • protect from excessive heat (40°C/104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, diazolidinyl urea, glyceryl stearate/PEG-100 stearate, methylparaben, propylene glycol, propylparaben, purified water

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-632-6900

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

antiitch-cream-labelantiitch-cream-labelantiitch-cream-ifcantiitch-cream-ifc

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN2
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD2
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY2

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-130041260026782GTIN-13: 0041260026782
EAN-13: 0041260026782
GTIN-12: 041260026782
UPC-A: 041260026782
GTIN storage (14 digits): 00041260026782		antiitch-cream-ifc.jpg

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
41226-888-02Anti-Itch Cream1 in 1 CARTONCREAM12
41226-888-02Anti-Itch Cream28 g in 1 TUBECREAM282

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
41226-88841226-888-02

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
PROPYLPARABENZ8IX2SC1OHIACT
CETYL ALCOHOL936JST6JCNIACT
ZINC ACETATEFM5526K07AACTIB
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
WATER059QF0KO0RIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEKroger3f881349-fcdd-e276-e063-6394a90ae49e2025-11-13WarningsExact identifier
ndc (package): 41226-888-02
ndc (product): 41226-888
ndc11 (package): 41226088802
spl id: 43753a0c-e471-2c8e-e063-6394a90a016d
spl set id: 3f881349-fcdd-e276-e063-6394a90ae49e

Reported adverse events (FAERS/openFDA)#

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