Itch Stopping Cream

Manufacturer
Anicare Pharmaceuticals Pvt. Ltd.
Effective date
2020-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:38

Label at a glance#

ProductLucky Itch Stopping
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure12 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 than directed  ■ adults and children2 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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

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 ■ on chicken pox ■ on measles

Ask a doctor before use

OTC - WHEN USING SECTION

avoid 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 wihin a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

■ do not use more than directed 

■ adults and children2 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

SPL UNCLASSIFIED SECTION

■ store at 20 to 25C (68-77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, diazolidinyl urea, methylparaben, propylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47046-168-012022-01-28C16284748780-1d6a99b39-e782-a426-e053-dadaa90af4c2Itch Stopping Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47046-168-01LuckyItch Stopping35.4 g in 1 TUBECREAM35.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47046-168LUCKY ITCH STOPPING (DIPHENHYDRAMINE HYDROCHLORIDE ZINC ACETATE) CREAM [ANICARE PHARMACEUTICALS PVT. LTD.]1Legacy NDC, 1 package rows20201221_b6e14e7f-8533-3de7-e053-2995a90a0e46.zip

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
47046-16847046-168-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
b6e1633b-487f-3a0b-e053-2a95a90add6eb6e14e7f-8533-3de7-e053-2995a90a0e462020-12-20WarningsExact identifier
spl id: b6e1633b-487f-3a0b-e053-2a95a90add6e
spl set id: b6e14e7f-8533-3de7-e053-2995a90a0e46

Reported adverse events (FAERS/openFDA)#

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