FDA.reportPublic FDA data

Anti-Itch Cream

Manufacturer
Trifecta Pharmaceuticals USA, LLC.
Effective date
2024-01-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:06:23

Label at a glance#

ProductAnti-Itch Cream
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure13 sections

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 20º-25ºC (68º-77ºF) Close cap tightly after use Questions? Call 1-888-296-9067

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

INDICATIONS & USAGE SECTION

For the temporary relief from pain and itching associated with

  • insect bites
  • minor burns
  • minor skin irritation
  • rashes due to poison ivy, poison oak, and poison sumac
  • dries the 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 on chicken pox or measles

When using this product avoid contact with eyes

Stop use and ask a doctor if

  • 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

Stop use and ask a doctor

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 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 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 20º-25ºC (68º-77ºF)
  • Close cap tightly after use

Questions? Call 1-888-296-9067

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Distributed By:

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

Product of PRC

www.trifecta-pharma.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Globe Anti-itch Cream 1.5oz Rev10 062422 CDERGlobe Anti-itch Cream 1.5oz Rev10 062422 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN5
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD5
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY5

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-025-05Anti-Itch Cream1 in 1 BOXCREAM15
69396-025-05Anti-Itch Cream15 g in 1 TUBECREAM155
69396-025-15Anti-Itch Cream42 g in 1 TUBECREAM425
69396-025-15Anti-Itch Cream1 in 1 BOXCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-025ANTI-ITCH CREAM (DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%) CREAM [TRIFECTA PHARMACEUTICALS USA, LLC.]5Current NDC, Legacy NDC, 4 package rows20240103_44d17651-a31b-64ca-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-025-05GM - Gram69396-0250632feb3-c28a-47f3-9ffc-ea4d7c5dc36212018-06-11

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
69396-02569396-025-05, 69396-025-15

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

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 2%, ZINC ACETATE 0.1%Trifecta Pharmaceuticals USA, LLC.44d17651-a31b-64ca-e054-00144ff8d46c2024-01-02WarningsExact identifier
ndc (package): 69396-025-05
ndc (package): 69396-025-15
ndc (product): 69396-025
ndc11 (package): 69396002505
ndc11 (package): 69396002515
spl id: 0df7f83e-5adb-ec48-e063-6294a90a198e
spl set id: 44d17651-a31b-64ca-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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