Itch stopping Cream

Manufacturer
Trifecta Pharmaceuticals USA, LLC.
Effective date
2024-02-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:30

Label at a glance#

ProductItch stopping Cream
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure16 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

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

Temporarily relieves pain and itching associated with

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

Warnings

WARNINGS SECTION

For External Use Only

Do Not Use

OTC - DO NOT USE SECTION

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

When Using this product

OTC - WHEN USING SECTION

When Using this Product avoid contact with Eyes

Stop Use and Ask a Doctor If

OTC - STOP USE SECTION

Stop Use and Ask a Doctor if

  • Conditions worsen or do not improve within 7 days
  • Symptoms presist 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

Ask a Doctor before Use

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use on chicken pox or measles

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Proudly Distributed by Associated Wholesale Grocers Inc.

Kansas City, KS. 66106 USA

Questions Call: 1-877-753-3935

Monday-Friday 9AM-5PM EST

This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Extra Strength Benadryl® Itch Stopping Cream.

00000 Rev0000000000

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best Choice Itch Stopping Cream 1oz 040523 CDERBest Choice Itch Stopping Cream 1oz 040523 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN1
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD1
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY1

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
69396-150-01Itch stopping Cream1 in 1 BOXCREAM11
69396-150-01Itch stopping Cream28.3 g in 1 TUBECREAM28.31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-150ITCH STOPPING CREAM (DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%) CREAM [TRIFECTA PHARMACEUTICALS USA, LLC.]1Current NDC, 2 package rows20240214_11368823-d4af-a536-e063-6294a90a7a2e.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
69396-15069396-150-01

Ingredients#

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

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

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
Itch stopping CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Trifecta Pharmaceuticals USA, LLC.11368823-d4af-a536-e063-6294a90a7a2e2024-02-12WarningsExact identifier
ndc (package): 69396-150-01
ndc (product): 69396-150
ndc11 (package): 69396015001
spl id: 11368833-d279-8c29-e063-6294a90a3260
spl set id: 11368823-d4af-a536-e063-6294a90a7a2e

Reported adverse events (FAERS/openFDA)#

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