FDA.reportPublic FDA data

Dr. Sheffield Anti Itch Cream

Manufacturer
Sheffield Pharmaceuticals LLC
Effective date
2023-10-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:58:25

Label at a glance#

ProductDr. Sheffield Anti Itch Cream
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure9 sections

Indications and uses

For temporary relief from pain and itching associated with : insect bites minor burns sunburn minor skin irritations rashes due to poison ivy, poison oak, and poison sumac Dries the oozing and weeping of poison ivy oak sumac

Dosage and administration

do not use more than directed adults and children 2 years of age and older; apply to affected areas not more than 3 to 4 times daily children under 2 years of age , consult a doctor Other Information Store at controlled room temperature 20°-25°C (68° - 77°F) Close the cap tightly after use

Label contents#

Full prescribing information#

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

For temporary relief from pain and itching associated with :

  • insect bites
  • minor burns
  • sunburn
  • minor skin irritations
  • rashes due to poison ivy, poison oak, and poison sumac

Dries the oozing and weeping of poison

  • ivy
  • oak
  • 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 the 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

  • conditions worsen or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur agian within a few days

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • adults and children 2 years of age and older; apply to affected areas not more than 3 to 4 times daily
  • children under 2 years of age , consult a doctor

Other Information

  • Store at controlled room temperature 20°-25°C (68° - 77°F)
  • Close the cap tightly after use

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cetyl Alcohol, Diazolldinyl Urea, Methylparaben, PEG 20 Sterate, Proplylene Glycol, Proplyparaben, Purified Water

Principal Display Panel 1.25 oz Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheffield  Pharmaceuticals                              NDC 11527-069-04

ANTI -ITCH cream

Topical analgesic & Skin Protectant

Made in the USA                       NET WT. 1.25 oz ( 35g)

Principal Display Panel 1.25 oz CartonPrincipal Display Panel 1.25 oz Carton

Principal Display Panel 1.25 oz Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheffield Pharmaceuticals                                              NDC 11527-069-04

    2% Diphenhydramine Hydrochloride and 0.1% Zinc Acetate

ANTI-ITCH cream          

 Histamine blocker relieves itching from insect bites & skin irritations

Topical Analgesic & Skin Protectant                 

NET WT. 1.25oz ( 35g)

Principal Display Panel 1.25 oz TubePrincipal Display Panel 1.25 oz Tube

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
11527-069-042021-11-24C16284748780-19d75b9d0-585d-f424-e053-dadaa90a57ceSheffield Extra Strength Anti- Itch Cream
11527-069-042020-01-31C16284748780-19d75b9d0-585d-f424-e053-dadaa90a57ceSheffield Extra Strength Anti- Itch Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-069-04Dr. Sheffield Anti Itch Cream35 g in 1 TUBECREAM353
11527-069-04Dr. Sheffield Anti Itch Cream1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-069DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [SHEFFIELD PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 2 package rows20231031_77f0593e-f694-4c02-9fd9-ad56ff2a920c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-069-04GM - Gram11527-06943a1f25b-33f7-4fd3-b5cf-f4abb6578be412021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD401
ZINC ACETATEACTIVE INGREDIENTFM5526K07A1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M1
ZINC CATIONACTIVE MOIETY13S1S8SF371
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW41
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PEG-20 STEARATEINACTIVE INGREDIENTNBX892EA571
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
11527-06911527-069-04

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
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
PEG-20 STEARATENBX892EA57IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT

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 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 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
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 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
Dr. Sheffield Anti Itch CreamANTI ITCH CREAMSheffield Pharmaceuticals LLC77f0593e-f694-4c02-9fd9-ad56ff2a920c2023-10-30WarningsExact identifier
ndc (package): 11527-069-04
ndc (product): 11527-069
ndc11 (package): 11527006904
spl id: 36f56c5a-15fe-4243-83a4-e9a54eca9a13
spl set id: 77f0593e-f694-4c02-9fd9-ad56ff2a920c

Reported adverse events (FAERS/openFDA)#

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