FDA.reportPublic FDA data

Shopko ® Anti-Itch Cream

Manufacturer
Shopko Stores Operating Co., LLC | Sun Pharma Canada Inc.
Effective date
2025-07-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:07:13

Label at a glance#

ProductShopko Anti-Itch
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure9 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 often 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

To open: unscrew cap, use pointed end of cap to puncture seal. store at 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Diphenhydramine hydrochloride 2%Topical analgesic
Zinc acetate 0.1%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

OTC - WHEN USING SECTION

When using this productavoid 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 often 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

STORAGE AND HANDLING SECTION

  • To open: unscrew cap, use pointed end of cap to puncture seal.
  • store at 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHOPKO®

NDC 37012-089-02

Extra Strength
Anti-Itch Cream
Diphenhydramine hydrochloride 2% and Zinc acetate 0.1%

Antihistamine • Topical Analgesic • Skin Protectant

NET WT 1OZ (28.4 g)

Principal Display Panel - 28.4 g Tube Carton
Principal Display Panel - 28.4 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN3
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD3
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY3

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
37012-089-022024-11-15C16284748780-19d75b9cf-f78e-f424-e053-dadaa90a57ceShopko ® Anti-Itch Cream
37012-089-022020-01-31C16284748780-19d75b9cf-f78e-f424-e053-dadaa90a57ceShopko ® Anti-Itch Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37012-089-02Shopko Anti-Itch28.4 g in 1 TUBECREAM28.43
37012-089-02Shopko Anti-Itch1 in 1 CARTONCREAM13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD401
zinc acetateACTIVE INGREDIENTFM5526K07A1
diphenhydramineACTIVE MOIETY8GTS82S83M1
zinc cationACTIVE MOIETY13S1S8SF371
cetyl alcoholINACTIVE INGREDIENT936JST6JCN1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE41
methylparabenINACTIVE INGREDIENTA2I8C7HI9T1
PEG-100 stearateINACTIVE INGREDIENTYD01N1999R1
propylene glycolINACTIVE INGREDIENT6DC9Q167V31
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
waterINACTIVE INGREDIENT059QF0KO0R1

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
37012-08937012-089-02

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
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ZINC ACETATEFM5526K07AACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PEG-100 stearatePEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEG-100 stearatePEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Shopko Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEShopko Stores Operating Co., LLC130119eb-b87e-4a07-8d2a-317369bfa5412025-07-14WarningsExact identifier
ndc (package): 37012-089-02
ndc (product): 37012-089
ndc11 (package): 37012008902
spl id: 39e53a54-ad67-5db4-e063-6294a90aa72e
spl set id: 130119eb-b87e-4a07-8d2a-317369bfa541

Reported adverse events (FAERS/openFDA)#

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