FDA.reportPublic FDA data

Itch Relief Cream

Manufacturer
Pharmacy Value Alliance LLC | Trifecta Pharmaceuticals USA
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:47:23

Label at a glance#

ProductItch Relief Cream
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure14 sections

Indications and uses

For the temporary relief from pain and itcing assciated with: insect bites minor burns sunburn minor skin irritation minor cuts rashes due to poison ivy, poison oak, and poison sumac dries weeping and oozing of poison ivy, oak, and 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: consult a doctor

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 2%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Acetate 0.1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

For the temporary relief from pain and itcing assciated with:

  • insect bites
  • minor burns
  • sunburn
  • minor skin irritation
  • minor cuts
  • rashes due to poison ivy, poison oak, and poison sumac
  • dries weeping and oozing of poison ivy, oak, and sumac

Warnings

WARNINGS SECTION

For External Use only

Do not use on large areas of the body or with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use if you have chicken pox or measles

When using this product avoid contact with eyes.

Stop Use and ask a doctor if

OTC - STOP USE SECTION

  • Conditions worsen or do 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 the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact 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 area not more than 3 to 4 times daily
  • Children under 2 years of age: consult a doctor

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera (Aloe Barbadensis), leaf juice, Cetyl alcohol, Glyceryl monostearate, Methylparaben, Mineral Pil, Petrolatum, Polyoxyethylene, lauryl ether, Propylene glycol, Propylparaben, Purified Water, Stearic acid

Itch Relief Cream Antihistamine Topical Analgesic Skin Protectant

SPL UNCLASSIFIED SECTION

Temporarily relieves the itching and pain associated with:

  • insect bites
  • allergic itch
  • skin irritations

Distributed By:

SPL UNCLASSIFIED SECTION

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue

Wayne, PA. 19087

www.emersongroup.com

Product of PRC

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Itch Relief CreamItch Relief Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN8
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD8
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY8

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
68016-163-012023-05-09C16284748780-1ba0f9c33-41c7-a910-e053-dadaa90a0b85Itch Relief Cream
68016-163-012023-01-30C16284748780-1ba0f9c33-41c7-a910-e053-dadaa90a0b85Itch Relief Cream
68016-163-012021-08-10C16284748780-1ba0f9c33-41c7-a910-e053-dadaa90a0b85Itch Relief Cream
68016-163-012021-01-29C16284748780-1ba0f9c33-41c7-a910-e053-dadaa90a0b85Itch Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-163-01Itch Relief Cream28 g in 1 TUBECREAM288
68016-163-01Itch Relief Cream1 in 1 BOXCREAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-163ITCH RELIEF CREAM (ZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%) CREAM [PHARMACY VALUE ALLIANCE LLC]8Current NDC, Legacy NDC, 2 package rows20241222_37fe6d82-adee-4f58-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-16368016-163-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PETROLATUM4T6H12BN9UIACT
LAURETH-23N72LMW566GIACT
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PROPYLPARABENZ8IX2SC1OHIACT
STEARYL ALCOHOL2KR89I4H1YIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT
ZINC ACETATEFM5526K07AACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT

Source Document#

Source XML · Source PDF

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
Itch Relief CreamZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%Pharmacy Value Alliance LLC37fe6d82-adee-4f58-e054-00144ff88e882024-12-20WarningsExact identifier
ndc (package): 68016-163-01
ndc (product): 68016-163
ndc11 (package): 68016016301
spl id: 29b74830-5473-c90b-e063-6294a90a4e72
spl set id: 37fe6d82-adee-4f58-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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